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

    RAPIDHCG PREGNANCY TEST

    K Number: K981770 · Decision Jun 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    374
    Applicant Total
    4
    Review Days
    17

    Basic Information

    Device Name
    RAPIDHCG PREGNANCY TEST
    K Number
    K981770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RAPID DIAGNOSTICS, INC.
    Date Received
    May 19, 1998
    Decision Date
    June 5, 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 RAPID DIAGNOSTICS, INC.

    K Number Device Name
    K033566 MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
    K020716 RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
    K003809 RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS