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510(k) Data Aggregation

    K Number
    K971223
    Device Name
    CRYO CHECK FACTOR V DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-22

    (111 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CRYO CHECK FACTOR V DEFICIENT PLASMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor V deficiencies in in vitro clot-based factor V assays using the one stage prothrombin time.

    Device Description

    CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor V Deficient Plasma." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    However, the document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, or detailed performance metrics of the device as requested in your prompt. It is a regulatory approval letter, not a detailed technical or clinical study report.

    Therefore, I cannot extract the requested information from this text.

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