BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Psychemedics Microplate EIA for Cotinine in Hair

    K Number: K192517 · Decision Apr 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    222

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    Basic Information

    Device Name
    Psychemedics Microplate EIA for Cotinine in Hair
    K Number
    K192517
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psychemedics Corporation
    Date Received
    September 13, 2019
    Decision Date
    April 22, 2020
    Product Code
    MKU
    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
    MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MKU), ordered by most recent decision date.

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    COZART EIA COTININE URINE KIT

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    MICRO-PLATE COTININE EIA

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    AUTO-LYTE COTININE EIA

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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
    K182103 Psychemedics Microplate EIA for Fentanyl in Hair
    K163590 Psychemedics Microplate EIA for Benzodiazepines in Hair