FDA 510K (K014008) HEMOCHRON JR. CITRATE APTT CUVETTE

FDA 510K (K014008) HEMOCHRON JR. CITRATE APTT CUVETTE

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Device Classification Name    Activated Partial Thromboplastin
510(k) Number    K014008
Device Name    HEMOCHRON JR. CITRATE APTT CUVETTE
Applicant    ITC, INC.
Regulation Number    864.7925
Classification Product Code    GFO  
Date Received    12/05/2001
Decision Date    01/24/2002
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Hematology

Total pages: 86
Fully redacted pages: 5
Content pages: 81

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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