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

    IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40

    K Number: K883148 · Decision Dec 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    77
    Review Days
    132

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    Basic Information

    Device Name
    IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
    K Number
    K883148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    July 26, 1988
    Decision Date
    December 5, 1988
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

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    Other Clearances by Diagnostic Chemicals, Ltd. (Usa)

    K Number Device Name
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    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) →