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

    RAICHEM(TM) ALCOHOL REAGENT

    K Number: K874382 · Decision Jan 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    63
    Review Days
    77

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    Basic Information

    Device Name
    RAICHEM(TM) ALCOHOL REAGENT
    K Number
    K874382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    October 26, 1987
    Decision Date
    January 11, 1988
    Product Code
    DML
    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
    DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

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    Other Clearances by Reagents Applications, Inc.

    K Number Device Name
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    K915191 RAI-TROL ELEVATED LIPIDS CONTROL
    K913398 RAICHEM(TM) CREATINE KINASE-MB REAGENT
    K911900 RAICHEM SPIA C3 REAGENT
    K911899 RAICHEM SPIA C4 REAGENT
    K911898 RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
    K905084 RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
    K905085 RAICHEM GGT REAGENT
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