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

    ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

    K Number: K951853 · Decision Aug 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    14
    Review Days
    487

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    Basic Information

    Device Name
    ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
    K Number
    K951853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tcpi, Inc.
    Date Received
    April 21, 1995
    Decision Date
    August 20, 1996
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Tcpi, Inc.

    K Number Device Name
    K981363 ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
    K972960 HEALTH CHECK URI-TEST PROTEIN IN URINE
    K981197 ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
    K980776 ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
    K954968 HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
    K954685 URITEST - NITRITE IN URINE TEST
    K955353 ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
    K951892 ONE STEP URINE DRUG OF ABUSE COCAINE TEST
    K952096 ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)
    K941765 HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
    Search all 14 clearances from Tcpi, Inc. →