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

    PARAMAX ALCOHOL REAGENT

    K Number: K934275 · Decision Apr 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    72
    Review Days
    238

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    Basic Information

    Device Name
    PARAMAX ALCOHOL REAGENT
    K Number
    K934275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    August 31, 1993
    Decision Date
    April 26, 1994
    Product Code
    DIC
    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
    DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

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