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510(k) Data Aggregation

    K Number
    K121247
    Device Name
    ALCO-SCREEN
    Manufacturer
    CHEMATICS, INC.
    Date Cleared
    2013-03-22

    (331 days)

    Product Code
    DIC
    Regulation Number
    862.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEMATICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.
    Device Description
    ALCO-SCREEN® is a visually read semi-quantitative test for the detection of alcohol in saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 5 different cut-off levels. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
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    K Number
    K121256
    Device Name
    ALCO-SCREEN 02
    Manufacturer
    CHEMATICS, INC.
    Date Cleared
    2012-09-12

    (140 days)

    Product Code
    DIC
    Regulation Number
    862.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEMATICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
    Device Description
    ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
    Ask a Question

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