BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)

    K Number: K932766 · Decision Dec 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    77
    Review Days
    185

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    Basic Information

    Device Name
    HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    K Number
    K932766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    June 8, 1993
    Decision Date
    December 10, 1993
    Product Code
    LBR
    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
    LBR Ldl & Vldl Precipitation, Hdl

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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
    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) →