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

    SPAC DIGOXIN KIT

    K Number: K760800 · Decision Nov 1, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    92
    Review Days
    24

    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
    SPAC DIGOXIN KIT
    K Number
    K760800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    October 8, 1976
    Decision Date
    November 1, 1976
    Product Code
    DON
    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
    DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.

    Similar 510(k) Clearances

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

    CIBA CORNING ACS DIGOXIN IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MAGIC 125I DIGOXIN RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHASE II DIGOXIN RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ZETAPHASE-DIG

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENZYMUNE-TEST DIGOXIN

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

    Other Clearances by Mallinckrodt Critical Care

    K Number Device Name
    K880343 BURNEY GALLBLADDER CATHETER KIT
    K874605 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
    K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
    K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
    K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
    K873461 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
    K873833 THERMOCOUPLE ADAPTER
    K873004 GUIDING CATHETER
    K871204 CUFFED TRACHEAL TUBE (MULTIPLE)
    K862666 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
    Search all 92 clearances from Mallinckrodt Critical Care →