BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICROSAMPLE BLOOD COLLECTION DEVICE

    K Number: K761137 · Decision Feb 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    24
    Review Days
    75

    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
    MICROSAMPLE BLOOD COLLECTION DEVICE
    K Number
    K761137
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    November 24, 1976
    Decision Date
    February 7, 1977
    Product Code
    GKH
    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
    GKH Apparatus, Automated Blood Cell Diluting

    Similar 510(k) Clearances

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

    CELLTRACKS AUTOPREP SYSTEM MODEL:9541

    FDA 510(k)
    FDA Class 1 ·Hematology

    IMMUNICON CELLTRACKS AUTOPREP SYSTEM

    FDA 510(k)
    FDA Class 1 ·Hematology

    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER CELLPREP

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER MULTI Q PREP

    FDA 510(k)
    FDA Class 1 ·Hematology

    COULTER MULTI-Q-PREP

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by Ortho Diagnostics, Inc.

    K Number Device Name
    K802404 ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
    K801507 ANTIGEN CONTROL CELLS
    K800357 BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
    K800310 ORTHO ANTISERA CONTROL
    K791791 ORTHO ANTIBODY ENHANCEMENT SOLUTION
    K791301 ORTHO TSH RIA KIT
    K790813 MULTECON BLOOD GAS CONTROL
    K782063 PREGNANCY, SENSIDEX TUBE TEST
    K782166 SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
    K781638 RUBINDEX*DIRECT SYSTEM
    Search all 24 clearances from Ortho Diagnostics, Inc. →