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

    DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT

    K Number: K810966 · Decision Apr 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    32
    Review Days
    13

    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
    DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
    K Number
    K810966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E. R. Squibb & Sons, Inc.
    Date Received
    April 8, 1981
    Decision Date
    April 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

    DIGOXIN (RIA) 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 E. R. Squibb & Sons, Inc.

    K Number Device Name
    K821494 RIA STAT 16
    K820616 ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
    K820340 T3 UPTAKE-SQUIBB DIAGNOSTIC KIT
    K820341 CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
    K811240 SUR-FIT LOOP OSTOMY O.R. SET
    K811239 SUR-FIT DISPOSABLE CONVEX INSERT
    K811160 SUR-FIT IRRIGATION SLEEVE
    K811163 SUR-FIT DISPOSABLE FANGE CAP
    K810211 T3 RIA KIT
    K803100 STOMAHESIVE PASTE PROTECTIVE SKIN BARR
    Search all 32 clearances from E. R. Squibb & Sons, Inc. →