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

    BIOCEPT-G

    K Number: K760336 · Decision Nov 12, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    12
    Review Days
    105

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    Basic Information

    Device Name
    BIOCEPT-G
    K Number
    K760336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Wampole Laboratories
    Date Received
    July 30, 1976
    Decision Date
    November 12, 1976
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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