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

    ORTHO BRAND HOME PREGNANCY TEST

    K Number: K842265 · Decision Jul 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    ORTHO BRAND HOME PREGNANCY TEST
    K Number
    K842265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Advanced Care Products
    Date Received
    June 7, 1984
    Decision Date
    July 17, 1984
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Advanced Care Products

    K Number Device Name
    K945846 ADVANCE(R) PREGNANCY TEST
    K880472 ADVANCE* AND DAISY* PREGNANCY TEST
    K871601 ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
    K853142 OVUTIME OVULATION PREDICTOR TEST
    K834270 ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST