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

    PSYCHEMEDICS RIA COCAINE ASSAY

    K Number: K010868 · Decision Nov 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    12
    Review Days
    228

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    Basic Information

    Device Name
    PSYCHEMEDICS RIA COCAINE ASSAY
    K Number
    K010868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psychemedics Corp.
    Date Received
    March 23, 2001
    Decision Date
    November 6, 2001
    Product Code
    KLN
    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
    KLN Radioimmunoassay, Cocaine Metabolite

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    Other Clearances by Psychemedics Corp.

    K Number Device Name
    K130811 PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
    K123799 PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
    K111928 PSYCHEMEDICS PHENCYCLIDINE EIA
    K111927 PSYCHEMEDICS METHAMPHETAMINE EIA
    K111926 PSYCHEMEDICS OPIATES EIA
    K111925 PSYCHEMEDICS COCAINE EIA
    K111929 PSYCHEMEDICS CANNABINOIDS EIA
    K011426 PSYCHEMEDICS RIA CANNABINOID ASSAY
    K011275 PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
    K011185 PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
    Search all 12 clearances from Psychemedics Corp. →