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

    AMES TDA GENTAMICIN TEST

    K Number: K810942 · Decision Apr 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    158
    Review Days
    10

    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
    AMES TDA GENTAMICIN TEST
    K Number
    K810942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    April 7, 1981
    Decision Date
    April 17, 1981
    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 Miles Laboratories, Inc.

    K Number Device Name
    K880605 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
    K874909 MICRO-BUMINTEST REAGENT TABLETS
    K875079 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
    K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
    K872120 SERALYZER III BLOOD CHEMISTRY ANALYZER
    K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
    K872634 CUTTER PUREFLO PLUS IV FILTER
    K870214 MODIFIED SALTEX REAGENT STRIPS
    K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
    K865053 SERA-TEK MICROSOMAL ANTIBODY TEST
    Search all 158 clearances from Miles Laboratories, Inc. →