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

    I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS

    K Number: K945522 · Decision Dec 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    11
    Review Days
    32

    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
    I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
    K Number
    K945522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman-Diagnostic Systems Group
    Date Received
    November 10, 1994
    Decision Date
    December 12, 1994
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTEX IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD

    FDA 510(k)
    FDA Class 2 ·Immunology

    RAICHEM(TM) SPIA(TM) IGM REAGENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Beckman-Diagnostic Systems Group

    K Number Device Name
    K944605 CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
    K944604 CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
    K944606 CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
    K942676 SYNCHRON CX3 DELTA
    K934293 BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
    K934068 BECKMAN DIRECT BILIRUBIN REAGENT
    K936184 VIGIL PRX CHEMISTRY CONTROL
    K934271 BECKMAN SYNCHRON LACTATE REAGENT
    K934046 BECKMAN CHOLESTEROL REAGENT
    K934467 BECKMAN CX AMMONIA/ALCOHOL CONTROL
    Search all 11 clearances from Beckman-Diagnostic Systems Group →