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

    SIMULTEST CD3/ANTI-HLA-DR

    K Number: K924587 · Decision Aug 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    21
    Review Days
    329

    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
    SIMULTEST CD3/ANTI-HLA-DR
    K Number
    K924587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Becton Dickinson Immunocytometry Systems
    Date Received
    September 10, 1992
    Decision Date
    August 5, 1993
    Product Code
    GKZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GKZ Counter, Differential Cell

    Similar 510(k) Clearances

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

    XR-Series (XR-10, XR-20) Automated Hematology Analyzers

    FDA 510(k)
    FDA Class 2 ·Hematology

    Athelas Home

    FDA 510(k)
    FDA Class 2 ·Hematology

    Tru Hematology Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    Sysmex XR-Series (XR-10) Automated Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Sysmex XR-Series (XR-20) Automated Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Alinity h-series System

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

    Other Clearances by Becton Dickinson Immunocytometry Systems

    K Number Device Name
    K040026 BD FACS 7-COLOR SETUP BEADS
    K040725 BD FACSCANTO SYSTEM
    K980858 MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
    K974360 MULTITEST CD3/CD8/CD45/CD4
    K973483 FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
    K971205 TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
    K971110 TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
    K970326 TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
    K965053 TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES
    K970742 TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
    Search all 21 clearances from Becton Dickinson Immunocytometry Systems →