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

    EZ-SCREEN CANNABINOID/COCAINE

    K Number: K883105 · Decision Dec 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    6
    Review Days
    144

    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
    EZ-SCREEN CANNABINOID/COCAINE
    K Number
    K883105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Environmental Diagnostics, Inc.
    Date Received
    July 25, 1988
    Decision Date
    December 16, 1988
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

    Similar 510(k) Clearances

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

    Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DRI Cocaine Metabolite Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DRI Cocaine Metabolite Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Emit II Plus Cocaine Metabolite Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

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

    Other Clearances by Environmental Diagnostics, Inc.

    K Number Device Name
    K905700 EZ-SCREEN: AMPHETAMINES
    K905057 EZ-SCREEN:BARBITURATES
    K902681 EZ-SCREEN:HCG
    K900203 EZ-SCREEN:OPIATES
    K862916 EZ-SCREEN: CANNABINOID