LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K011426
    Device Name
    PSYCHEMEDICS RIA CANNABINOID ASSAY
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2002-05-03

    (360 days)

    Product Code
    LAT
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    LAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K961620
    Device Name
    ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1996-06-13

    (48 days)

    Product Code
    LAT
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    LAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K936135
    Device Name
    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
    Manufacturer
    SUDORMED, INC.
    Date Cleared
    1996-06-10

    (895 days)

    Product Code
    LAT
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    LAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1