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

    Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

    K Number: K212952 · Decision Apr 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    214

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    Basic Information

    Device Name
    Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
    K Number
    K212952
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psychemedics Corporation
    Date Received
    September 16, 2021
    Decision Date
    April 18, 2022
    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 Psychemedics Corporation

    K Number Device Name
    K210212 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
    K201326 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
    K201228 Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
    K192517 Psychemedics Microplate EIA for Cotinine in Hair
    K182103 Psychemedics Microplate EIA for Fentanyl in Hair
    K163590 Psychemedics Microplate EIA for Benzodiazepines in Hair