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

    ALCO-SCREEN 02

    K Number: K121256 · Decision Sep 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    ALCO-SCREEN 02
    K Number
    K121256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chematics, Inc.
    Date Received
    April 25, 2012
    Decision Date
    September 12, 2012
    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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    Other Clearances by Chematics, Inc.

    K Number Device Name
    K121247 ALCO-SCREEN