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

    VERDICT -II TCA, VERDICT-II MTD

    K Number: K011545 · Decision Jun 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    20
    Applicant Total
    22
    Review Days
    21

    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
    VERDICT -II TCA, VERDICT-II MTD
    K Number
    K011545
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtox Diagnostics, Inc.
    Date Received
    May 18, 2001
    Decision Date
    June 8, 2001
    Product Code
    LFG
    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
    LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

    Similar 510(k) Clearances

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

    Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UCP MULTIPLE DRUG SCREEN TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE

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

    Other Clearances by Medtox Diagnostics, Inc.

    K Number Device Name
    K252684 Labcorp Fentanyl Urine Visual Test
    K100951 MEDTOX BUPRENORPHINE TEST
    K100023 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
    K091454 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
    K080635 MEDTOXSCAN
    K060351 MEDTOX OXYCODONE
    K050394 SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
    K033334 PROFILE -ER
    K031032 VERDICT II, PROFILE II
    K022141 VERDICT-II
    Search all 22 clearances from Medtox Diagnostics, Inc. →