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510(k) Data Aggregation

    K Number
    K971224
    Device Name
    CRYO CHECK FACTOR VII DEFICIENT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-07-17

    (106 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 VII DEFICIENT PLASMA

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

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

    Device Description

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

    AI/ML Overview

    This document does not contain the information required to answer your request. It is a 510(k) clearance letter for a medical device (CryoCheck Factor VII Deficient Plasma), which primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance. It does not include details on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment.

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