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

    MEDTOXSCAN

    K Number: K080635 · Decision Feb 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    22
    Review Days
    344

    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
    MEDTOXSCAN
    K Number
    K080635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtox Diagnostics, Inc.
    Date Received
    March 6, 2008
    Decision Date
    February 13, 2009
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKZ Enzyme Immunoassay, Amphetamine

    Similar 510(k) Clearances

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

    DRI Ecstasy Plus Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Quidel Triage® TOX Drug Screen, 94600

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

    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
    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
    K020787 VERDICT-II PROPOXYPHENE
    Search all 22 clearances from Medtox Diagnostics, Inc. →