BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST

    K Number: K963693 · Decision Nov 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    142
    Applicant Total
    72
    Review Days
    74

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    Basic Information

    Device Name
    OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
    K Number
    K963693
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    September 16, 1996
    Decision Date
    November 29, 1996
    Product Code
    CEP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEP Radioimmunoassay, Luteinizing Hormone

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