BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NICCHECK I

    K Number: K963733 · Decision Dec 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    88

    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
    NICCHECK I
    K Number
    K963733
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynagen, Inc.
    Date Received
    September 16, 1996
    Decision Date
    December 13, 1996
    Product Code
    MRS
    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
    MRS Test System, Nicotine, Cotinine, Metabolites

    Similar 510(k) Clearances

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

    DRI COTININE EIA ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    NICALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology
    View all

    Other Clearances by Dynagen, Inc.

    K Number Device Name
    K943049 MYCOAKT M. AVIUM CULTURE ID KIT
    K943051 MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
    K943050 MYCOAKT M KANSASII CULTURE ID KIT
    K931105 PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
    K912888 URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL