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

    Psychemedics Microplate EIA for Fentanyl in Hair

    K Number: K182103 · Decision Apr 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    7
    Review Days
    258

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    Basic Information

    Device Name
    Psychemedics Microplate EIA for Fentanyl in Hair
    K Number
    K182103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psychemedics Corporation
    Date Received
    August 3, 2018
    Decision Date
    April 18, 2019
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Psychemedics Corporation

    K Number Device Name
    K212952 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
    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
    K163590 Psychemedics Microplate EIA for Benzodiazepines in Hair