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

    ORTHO HEMATOLOGY CONTROL

    K Number: K803073 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    191
    Applicant Total
    6
    Review Days
    26

    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
    ORTHO HEMATOLOGY CONTROL
    K Number
    K803073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Instruments
    Date Received
    December 5, 1980
    Decision Date
    December 31, 1980
    Product Code
    JPK
    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
    JPK Mixture, Hematology Quality Control

    Similar 510(k) Clearances

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

    XN CHECK BF

    FDA 510(k)
    FDA Class 2 ·Hematology

    XN-L CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    XN CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    BC-5D Hematology Control

    FDA 510(k)
    FDA Class 2 ·Hematology

    XN CHECK BF

    FDA 510(k)
    FDA Class 2 ·Hematology

    XN CHECK

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

    Other Clearances by Ortho Instruments

    K Number Device Name
    K803084 ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
    K803083 ORTHO HEMOTOLOGY CONTROL-NORMAL
    K802094 ORTHO SPECTRUM
    K801545 ORTHO AUTOMATED CELL COUNTER
    K781146 HEMAC LASER HEMATOLOGY SYSTEM