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

    PROFILE -ER

    K Number: K033334 · Decision Nov 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    22
    Review Days
    25

    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
    PROFILE -ER
    K Number
    K033334
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtox Diagnostics, Inc.
    Date Received
    October 16, 2003
    Decision Date
    November 10, 2003
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

    Similar 510(k) Clearances

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

    Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CR3 Keyless Split Sample Cup Secobarbital- Methadone

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GenPrime Snap-Top Split Key Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

    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
    K031032 VERDICT II, PROFILE II
    K022141 VERDICT-II
    K020787 VERDICT-II PROPOXYPHENE
    Search all 22 clearances from Medtox Diagnostics, Inc. →