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

    BETA-HCG MICROTITER PREGNANCY TEST

    K Number: K853258 · Decision Oct 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    5
    Review Days
    60

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    Basic Information

    Device Name
    BETA-HCG MICROTITER PREGNANCY TEST
    K Number
    K853258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Modern Diagnostics, Inc.
    Date Received
    August 2, 1985
    Decision Date
    October 1, 1985
    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 Modern Diagnostics, Inc.

    K Number Device Name
    K853269 PREGNA/TEST
    K853006 HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
    K852840 ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
    K851369 ANTINUCLEAR ANTIBODY TEST KIT