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

    ENZYMATIC THEOPHYLLINE REAGENT, #500-82

    K Number: K901510 · Decision Jun 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    77
    Review Days
    74

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    Basic Information

    Device Name
    ENZYMATIC THEOPHYLLINE REAGENT, #500-82
    K Number
    K901510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    March 30, 1990
    Decision Date
    June 12, 1990
    Product Code
    KLS
    Advisory Committee
    Clinical Toxicology
    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
    KLS Enzyme Immunoassay, Theophylline

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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
    K974874 BILIRUBIN-SL (TOTAL) ASSAY
    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
    Search all 77 clearances from Diagnostic Chemicals, Ltd. (Usa) →