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

    DCA DIGOX-SYN RIA TEST

    K Number: K810477 · Decision Mar 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    16

    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
    DCA DIGOX-SYN RIA TEST
    K Number
    K810477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Corp. of America
    Date Received
    February 23, 1981
    Decision Date
    March 11, 1981
    Product Code
    DOG
    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
    DOG Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol

    Similar 510(k) Clearances

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

    IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGOXIN RIA (PEG) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT DIGOKIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DATA-TOPE SYSTEM DIGOXIN RIA

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

    Other Clearances by Diagnostic Corp. of America

    K Number Device Name
    K781150 RIA TSH IN HUMAN SERUM OR PLASMA
    K780412 TOTAL IRON BINDING CAPACITY