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

    URINE THC DIRECT RIA KIT (I-125)

    K Number: K913865 · Decision Sep 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    15
    Applicant Total
    50
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    URINE THC DIRECT RIA KIT (I-125)
    K Number
    K913865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immunalysis Corporation
    Date Received
    August 27, 1991
    Decision Date
    September 18, 1991
    Product Code
    LAT
    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
    LAT Radioimmunoassay, Cannabinoid(S)

    Similar 510(k) Clearances

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

    PSYCHEMEDICS RIA CANNABINOID ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN ONLINE FOR THC (50 AND 100)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Immunalysis Corporation

    K Number Device Name
    K252520 SEFRIA™ Hydrocodone Oral Fluid
    K232898 Quantisal™ Oral Fluid Collection Device
    K223781 Quantisal™ II Oral Fluid Collection Device
    K203647 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
    K203564 SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
    K203489 SEFRIA PCP Oral Fluid Enzyme Immunoassay
    K200801 Quantisal Oral Fluid Collection Device
    K190397 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
    K183048 Quantisal II Oral Fluid Collection Device
    K181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
    Search all 50 clearances from Immunalysis Corporation →