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

    DIGOXIN (RIA) KIT

    K Number: K811212 · Decision May 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    17

    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
    DIGOXIN (RIA) KIT
    K Number
    K811212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Assay Corp.
    Date Received
    May 4, 1981
    Decision Date
    May 21, 1981
    Product Code
    DNL
    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
    DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.

    Similar 510(k) Clearances

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

    DIG RADIOIMMUNOASSAY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TIPSEP DIGOXIN RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGOXIN RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TEST SET, 125 I-DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RIANEN ASSAY SYSTEM, 125I KIT

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

    Other Clearances by Immuno Assay Corp.

    K Number Device Name
    K833842 RIA COAT DIGOXIN
    K833745 RIACOAT T-4
    K820089 TSH (RIA) KIT
    K820074 CORTISOL (RIA) KIT
    K811954 COMBO-FER IRON DIAGNOSTIC
    K811725 TBG DIAGNOSTIC KIT
    K811213 T3 (RIA) KIT
    K810857 T3 UPTAKE KIT
    K810811 T4 RIA KIT