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510(k) Data Aggregation

    K Number
    K081929
    Device Name
    VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2008-12-16

    (162 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR

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

    VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).

    Device Description

    Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a blood collection tube. It does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI-powered medical device.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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