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

    FIRST CHECK HOME DRUG TEST PANEL 4

    K Number: K993852 · Decision Nov 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    5
    Review Days
    383

    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
    FIRST CHECK HOME DRUG TEST PANEL 4
    K Number
    K993852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Worldwide Medical Corp.
    Date Received
    November 12, 1999
    Decision Date
    November 29, 2000
    Product Code
    LAF
    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
    LAF Gas Chromatography, Methamphetamine

    Similar 510(k) Clearances

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

    SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Rapid Tox Cup II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

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

    Other Clearances by Worldwide Medical Corp.

    K Number Device Name
    K020869 FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
    K994138 FIRST CHECK HOME DRUG TEST PANEL 3
    K993663 FIRST CHECK HOME DRUG TEST (THC)
    K994139 FIRST CHECK HOME DRUG TEST PANEL 2