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

    QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.

    K Number: K821862 · Decision Jul 6, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    92
    Review Days
    12

    Basic Information

    Device Name
    QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
    K Number
    K821862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    KALLESTAD LABORATORIES, INC.
    Date Received
    June 24, 1982
    Decision Date
    July 6, 1982
    Product Code
    LCA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCA Radioimmunoassay, Theophylline

    Similar 510(k) Clearances

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

    THEOPHYLLINE TEST KIT REF. #A874799

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THEOPHYLLINE RIASSAY

    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
    K855012 QUANTIMETRIC PLUS C4 REAGENT KIT
    K855007 QUANTIMETRIC PLUS LAMBDA REAGENT KIT
    Search all 92 clearances from KALLESTAD LABORATORIES, INC. →