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

    FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY

    K Number: K791547 · Decision Oct 12, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    319
    Review Days
    63

    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
    FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
    K Number
    K791547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Rad
    Date Received
    August 10, 1979
    Decision Date
    October 12, 1979
    Product Code
    DJB
    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
    DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

    Similar 510(k) Clearances

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

    AMES TDA SISOMICIN TEST-CONTROL SERUM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GENTAMICIN TEST PACK-ACA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AMES TDA GENTAMICIN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MRI GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COAT-A-COUNT GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GAMMA STICK GENTAMICIN RIA KIT

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

    Other Clearances by Bio-Rad

    K Number Device Name
    K171061 MRSASelect II
    K122187 VRESELECT CULTURE MEDIUM
    K103684 VRESELECT CULTURE MEDIUM
    K093678 PLATELIA ASPERGILLUS EIA MODEL 62793
    K100589 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
    K081362 PLATELIA LYME IGM
    K081212 MRSASELECT - EXTENDED INCUBATION
    K080012 PLATELIA LYME IGG ASSAY
    K070361 MRSASELECT
    K060641 PLATELIA ASPERGILLUS EIA, MODEL 62793
    Search all 319 clearances from Bio-Rad →