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

    DIGOXIN CLASP RIA KIT

    K Number: K800997 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    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
    DIGOXIN CLASP RIA KIT
    K Number
    K800997
    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 25, 1980
    Decision Date
    May 8, 1980
    Product Code
    LCS
    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
    LCS Radioimmunoassay, Digoxin (125-I)

    Similar 510(k) Clearances

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

    DIGOXIN COATED TUBE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QMS - DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR DIGOXIN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMMPULSE DIGOXIN ASSAY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DART DIGOXIN ASSAY

    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
    K810966 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
    K810211 T3 RIA KIT
    Search all 32 clearances from E. R. Squibb & Sons, Inc. →