BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BILIRUBIN-SL (TOTAL) ASSAY

    K Number: K974874 · Decision Feb 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    77
    Review Days
    45

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    Basic Information

    Device Name
    BILIRUBIN-SL (TOTAL) ASSAY
    K Number
    K974874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    December 29, 1997
    Decision Date
    February 12, 1998
    Product Code
    CIG
    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
    CIG Diazo Colorimetry, Bilirubin

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    Other Clearances by Diagnostic Chemicals, Ltd. (Usa)

    K Number Device Name
    K022538 IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
    K932556 AMMONIA ASSAY CAT. NO. 200-02
    K932766 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    K932555 DC-LINEATE CAT. NO. SE-091
    K925877 DC-UIBC-CAL
    K912825 MAGNESIUM ASSAY KIT, CAT.# 100-12
    K895964 DCL SYPHILIS-M CATALOG NO. 600-80
    K895965 DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
    K904660 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
    K901510 ENZYMATIC THEOPHYLLINE REAGENT, #500-82
    Search all 77 clearances from Diagnostic Chemicals, Ltd. (Usa) →