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

    Rapid Tox Cup II

    K Number: K170222 · Decision Aug 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    30
    Review Days
    202

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    Basic Information

    Device Name
    Rapid Tox Cup II
    K Number
    K170222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Bio Medica Corp.
    Date Received
    January 25, 2017
    Decision Date
    August 15, 2017
    Product Code
    LAF
    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
    LAF Gas Chromatography, Methamphetamine

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    Other Clearances by American Bio Medica Corp.

    K Number Device Name
    K073078 RAPID TOX CUP
    K060760 RAPIDONE-BUPRENORPHINE TEST
    K053422 RAPIDONE-COCAINE-150 TEST
    K053359 RAPIDTOX
    K041696 RAPID READER
    K041712 'RAPIDTEC 4' TEST
    K030835 'RAPID ONE' - PROPOXYPHENE TEST
    K023869 'RAPIDTEC'-5M-MULTIPLE DIP TEST
    K021114 'RAPIDTEC' 5A MULTIPLE DIP TEST
    K014101 RAPIDONE-OXY TEST
    Search all 30 clearances from American Bio Medica Corp. →