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

    MULTICHEM ALBUMIN REAGENT S0902

    K Number: K874049 · Decision Oct 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    23
    Review Days
    24

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    Basic Information

    Device Name
    MULTICHEM ALBUMIN REAGENT S0902
    K Number
    K874049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Simmler, Inc.
    Date Received
    October 5, 1987
    Decision Date
    October 29, 1987
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Simmler, Inc.

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    K874595 MULTICHEM (R) MAGNESIUM REAGENT
    K874820 MULTICHEM HDL PRECIPITATING REAGENT #S0914
    K874812 MULTICHEM CHLORIDE REAGENT S0933
    K874311 MULTICHEM (R) TOTAL BILIRUBIN
    K874038 MULTICHEM INORGANIC PHOSPHOROUS S0923
    K873725 MULTICHEM CREATININE REAGENT S0917
    K873761 MULTICHEM ALKALINE PHOSPHATASE (S0903)
    K873697 MULTICHEM CALCIUM S0910
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