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

    GENTAMICIN FLUROIMMUNASSAY KIT

    K Number: K782025 · Decision Jan 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    9
    Review Days
    52

    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
    GENTAMICIN FLUROIMMUNASSAY KIT
    K Number
    K782025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Technia Diagnostics , Ltd.
    Date Received
    December 5, 1978
    Decision Date
    January 26, 1979
    Product Code
    LCQ
    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
    LCQ Fluorescent Immunoassay Gentamicin

    Similar 510(k) Clearances

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

    VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR GENTAMICIN ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GENTAMICIN FPIA REAGENT SET AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OPUS GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    'TDXFLX ANALYZER

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

    Other Clearances by Technia Diagnostics , Ltd.

    K Number Device Name
    K861978 AUTOFLUOR V
    K801843 T3(125) RADIOIMMUNOASSAY KIT
    K801202 DIGOXIN RADIOIMMUNOASSAY KIT
    K801203 CORTISOL RADIOIMMUNOASSAY KIT
    K791361 T3 UPTAKE RADIOIMMUNOASSAY KIT
    K790919 HPL RIA KIT
    K790495 THYROXINE RIA KIT
    K782024 RIA KIT, VITAMIN B12