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510(k) Data Aggregation

    K Number
    K984071
    Manufacturer
    Date Cleared
    1998-12-03

    (17 days)

    Product Code
    Regulation Number
    862.1660
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644

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

    Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

    Device Description

    Liquichek Homocysteine Control is prepared from human serum with added Liquichek Homocystellie Control is propared from hands been is provided in liquid form for convenience. This product contains

    AI/ML Overview

    The provided text lacks information regarding acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Liquichek Homocysteine Control), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria and study results.

    Therefore, I cannot provide the requested information.

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