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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

14 rows where docket_id = "FDA-1985-P-0452" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, comment_start_date, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 4

  • Supporting & Related Material 8
  • Other 4
  • Proposed Rule 1
  • Rule 1

posted_year 1

  • 2008 14

agency_id 1

  • FDA 14
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-1985-P-0452-0014 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Appendix G - Volume 2 of 3 (Federal Register Document) - [513(e) Reclassification Petition for the Automated Heparin Analyzer - Medical Device Consultants, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-10-14T04:00:00Z 2008 10     2008-10-14T16:47:44Z   0 0 0900006480749947
FDA-1985-P-0452-0013 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Medical Device Consultants, Inc. - Citizen Petition - [513(e) Reclassification Petition for the Automated Heparin Analyzer] - Supplement Other SUP-Supplement 2008-10-14T04:00:00Z 2008 10 2008-10-14T04:00:00Z   2013-07-27T22:26:53Z   0 0 090000648073c113
FDA-1985-P-0452-0012 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 HemoTec, Inc. to the Office of Device Evaluation - Letter Other LET-Letter 2008-10-14T04:00:00Z 2008 10 2008-10-14T04:00:00Z   2008-10-14T15:43:20Z   0 0 09000064805b76ea
FDA-1985-P-0452-0004 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Appendix B "Supplemental Data Sheets for Automated Heparin Analyzer" - [513(e) Reclassification Petition for the Automated Heparin Analyzer - Medical Device Consultants, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-10-12T04:00:00Z 2008 10     2008-10-12T17:58:53Z   0 0 090000648073c631
FDA-1985-P-0452-0009 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Medical Devices; Reclassification of the Automated Heparin Analyzer Rule NFR-Notice of Final Rule 2008-10-12T04:00:00Z 2008 10 2008-10-12T04:00:00Z   2008-10-12T18:23:02Z   0 0 09000064805b76eb
FDA-1985-P-0452-0001 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Medical Device Consultants, Inc. (HemoTec, Inc.) - Citizen Petition Other CP-Citizen Petition 2008-10-12T04:00:00Z 2008 10 2008-10-12T04:00:00Z   2013-08-11T04:21:17Z   0 0 09000064805b76e8
FDA-1985-P-0452-0006 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Appendix D "Classified Coagulation Devices" - [Medical Device Consultants, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-10-12T04:00:00Z 2008 10     2008-10-12T17:58:55Z   0 0 090000648073c6d5
FDA-1985-P-0452-0010 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Memo Record "Telephone Conversations Between FDA and Dr. Robert F. Baugh" - (Medical Devices; Reclassification of the Automated Heparin Analyzer - Reference 15) re FDA-1985-P-0452-0008 - Background Material Supporting & Related Material BKG-Background Material 2008-10-12T04:00:00Z 2008 10     2008-10-14T16:21:41Z   0 0 090000648073c0a7
FDA-1985-P-0452-0002 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Acknowledgement Letter to Medical Device Consultants, Inc. Other ACK-Acknowledgement Letter 2008-10-12T04:00:00Z 2008 10 2008-10-12T04:00:00Z   2008-10-12T17:06:29Z   0 0 090000648073c0e0
FDA-1985-P-0452-0011 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Memo Record "Telephone Conversations Between FDA and Mr. Charles Gressle" - (Medical Devices; Reclassification of the Automated Heparin Analyzer - Reference 16) re FDA-1985-P-0452-0008 - Background Material Supporting & Related Material BKG-Background Material 2008-10-12T04:00:00Z 2008 10     2008-10-14T16:22:29Z   0 0 090000648073c0cd
FDA-1985-P-0452-0007 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Appendix E - "Regulatory Identification and Labeling Claims..." - 513(e) Reclassification Petition for the Automated Heparin Analyzer - Medical Device Consultants, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-10-12T04:00:00Z 2008 10     2008-10-12T17:58:56Z   0 0 090000648073c6da
FDA-1985-P-0452-0003 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Hematology and Pathology Devices Panel Conference Call Meeting (Medical Devices; Reclassification of the Automated Heparin Analyzer - Reference 14) re FDA-1985-P-0452-0008 - Background Material Supporting & Related Material BKG-Background Material 2008-10-12T04:00:00Z 2008 10     2008-10-14T16:20:46Z   0 0 090000648073c084
FDA-1985-P-0452-0005 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Appendix C "Classification Questionaires for Automated Heparin Analyzer" - [513(e) Reclassification Petition for the Automated Heparin Analyzer - Medical Device Consultants, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-10-12T04:00:00Z 2008 10     2008-10-12T17:58:54Z   0 0 090000648073c6b5
FDA-1985-P-0452-0008 FDA Reclassification Petition Under 513(E) for Automated Heparin Analyzer FDA-1985-P-0452 Medical Devices; Reclassification of the Automated Heparin Analyzer Proposed Rule NPR-Notice of Proposed Rule-Making 2008-10-12T04:00:00Z 2008 10 2008-10-12T04:00:00Z 1992-11-18T04:59:59Z 2008-10-12T18:23:00Z   0 0 09000064805b76e9

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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