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

    ACCESS DIGOXIN ASSAY

    K Number: K925802 · Decision Jan 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    82
    Review Days
    58

    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
    ACCESS DIGOXIN ASSAY
    K Number
    K925802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    November 16, 1992
    Decision Date
    January 13, 1993
    Product Code
    KXT
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXT Enzyme Immunoassay, Digoxin

    Similar 510(k) Clearances

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

    ADVIA Centaur® Digoxin assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX DIGOXIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXSYM DIGOXIN III

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

    Other Clearances by Bio-Rad Laboratories, Inc.

    K Number Device Name
    K181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
    K171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
    K161687 D-10 Hemoglobin A1c Program
    K151321 D-100 HbA1c, D-100 HbA1c Calibrator Pack
    K142448 VARIANT II TURBO HbA1c Kit - 2.0
    K140801 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
    K130053 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
    K130963 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
    K120504 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
    K120572 BIOPLEX 2200 TORC IGG
    Search all 82 clearances from Bio-Rad Laboratories, Inc. →