FDA 510K (K960749) HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

FDA 510K (K960749) HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

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Device Classification Name    Activated Whole Blood Clotting Time
510(k) Number    K960749
Device Name    HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
Applicant     INTERNATIONAL TECHNIDYNE CORP.
Regulation Number    864.7140
Classification Product Code    JBP  
Date Received    02/23/1996
Decision Date    08/12/1996
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Hematology

Total pages: 357
Fully redacted pages: 249
Content pages: 108

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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