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

    ALCO-SCREEN

    K Number: K121247 · Decision Mar 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    331

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ALCO-SCREEN
    K Number
    K121247
    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
    March 22, 2013
    Product Code
    DIC
    Advisory Committee
    Clinical Toxicology
    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
    DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DIC), ordered by most recent decision date.

    Sober Self-Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Immunalysis Ethyl Alcohol Enzyme Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALCO-SCREEN 02

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TECO DIAGNOSTICS SALIVA ALCOHOL TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX ETHANOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Chematics, Inc.

    K Number Device Name
    K121256 ALCO-SCREEN 02