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

    QUALITATIVE ENZYME IMMUNOASSAY-DETECT

    K Number: K832905 · Decision Feb 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    5
    Review Days
    158

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    Basic Information

    Device Name
    QUALITATIVE ENZYME IMMUNOASSAY-DETECT
    K Number
    K832905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Btc Diagnostics, Inc.
    Date Received
    August 29, 1983
    Decision Date
    February 3, 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 Btc Diagnostics, Inc.

    K Number Device Name
    K841545 ENZYME IMMUNOASSAY FOR DETECTION HORM
    K833710 BTC URINE LH ASSAY
    K831604 HCG ACCU-STICK
    K831125 BTC URINE LCG ASSAY