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

    RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR

    K Number: K122703 · Decision Apr 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    233

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    Basic Information

    Device Name
    RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
    K Number
    K122703
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biophor Diagnostics, Inc.
    Date Received
    September 4, 2012
    Decision Date
    April 25, 2013
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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    Other Clearances by Biophor Diagnostics, Inc.

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    K141748 RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
    K133047 RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
    K133642 RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
    K132096 RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR