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

    ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

    K Number: K980736 · Decision Apr 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
    K Number
    K980736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acon Laboratories Co.
    Date Received
    February 25, 1998
    Decision Date
    April 16, 1998
    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 Acon Laboratories Co.

    K Number Device Name
    K090057 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K061559 ACON URINALYSIS REAGENT STRIPS
    K023766 ACON STREP A TWIST TEST DEVICE
    K020313 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    K010582 ACON STREP A RAPID TEST STRIP