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

    HAEMOFUGE A. BIOFUGE A. & B

    K Number: K840767 · Decision Apr 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    54

    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
    HAEMOFUGE A. BIOFUGE A. & B
    K Number
    K840767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Heraeus-Christ GmbH
    Date Received
    February 23, 1984
    Decision Date
    April 17, 1984
    Product Code
    JPI
    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
    JPI Device, Hematocrit Measuring

    Similar 510(k) Clearances

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

    i-STAT CHEM8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Hematology

    i-STAT Hematocrit test with i-STAT Alinity System

    FDA 510(k)
    FDA Class 2 ·Hematology

    CRIT-LINE HEMATOCRIT ALERT

    FDA 510(k)
    FDA Class 2 ·Hematology

    CRIT-LINE

    FDA 510(k)
    FDA Class 2 ·Hematology

    STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES

    FDA 510(k)
    FDA Class 2 ·Hematology

    STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER

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

    Other Clearances by Heraeus-Christ GmbH

    K Number Device Name
    K840768 CENTRIFUGES