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

    BTC URINE LH ASSAY

    K Number: K833710 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    102

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    Basic Information

    Device Name
    BTC URINE LH ASSAY
    K Number
    K833710
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1520
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Btc Diagnostics, Inc.
    Date Received
    October 20, 1983
    Decision Date
    January 30, 1984
    Product Code
    CED
    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
    CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

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    Other Clearances by Btc Diagnostics, Inc.

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    K832905 QUALITATIVE ENZYME IMMUNOASSAY-DETECT
    K831604 HCG ACCU-STICK
    K831125 BTC URINE LCG ASSAY