BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ADVANTAGE HCG TEST (URINE/SERUM)

    K Number: K994227 · Decision Feb 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    ADVANTAGE HCG TEST (URINE/SERUM)
    K Number
    K994227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    December 15, 1999
    Decision Date
    February 3, 2000
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Advantage Diagnostics Corp.

    K Number Device Name
    K023712 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
    K013778 PEACE OF MIND HOME DRUG TEST
    K011962 ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
    K010921 ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
    K003708 ADVANTAGE THC/COCAINE TEST
    K001567 ADVANTAGE THC TEST
    K991883 REDI-TEST OPIATES
    K903416 CANNULA, SURGICAL
    K881369 ADVANCE DIAGNOSTICS DISPOSABLE EYECUP