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510(k) Data Aggregation

    K Number
    K011689
    Device Name
    HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
    Manufacturer
    CATCH, INC.
    Date Cleared
    2001-07-25

    (55 days)

    Product Code
    LPS
    Regulation Number
    862.1377
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
    Device Description
    Homogeneous Enzymic Homocysteine Reagent
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