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

    QUANTITOPE 125-I GENTAMICIN RIA KIT

    K Number: K780323 · Decision Mar 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    92
    Review Days
    18

    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
    QUANTITOPE 125-I GENTAMICIN RIA KIT
    K Number
    K780323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    February 27, 1978
    Decision Date
    March 17, 1978
    Product Code
    DJB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    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 Kallestad Laboratories, Inc.

    K Number Device Name
    K863681 PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
    K862917 PATHFINDER ROTAVIRUS CHEMILUMINESCENT
    K863682 PATHFINDER(TM) SPECIMEN COLLECTION KIT
    K862743 PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
    K862313 KALLESTAD SM/RNP TEST REAGENT
    K862710 KALLESTAD SSA/SSB ENA TEST REAGENTS
    K855014 QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
    K855010 QUANTIMETRIC PLUS IGM REAGENT KIT
    K855009 QUANTIMETRIC PLUS IGA REAGENT KIT
    K855008 QUANTIMETRIC PLUS KAPPA REAGENT KIT
    Search all 92 clearances from Kallestad Laboratories, Inc. →