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

    ACCESS FERRITIN ASSAY

    K Number: K926221 · Decision Jan 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    23
    Applicant Total
    82
    Review Days
    34

    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 FERRITIN ASSAY
    K Number
    K926221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    December 10, 1992
    Decision Date
    January 13, 1993
    Product Code
    JMG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

    Similar 510(k) Clearances

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

    Access Ferritin

    FDA 510(k)
    FDA Class 2 ·Immunology

    FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT FERRITIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELECSYS FERRITIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    FERR FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACE(TM) CEDIA(R) FERRITIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology
    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. →