BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    EUROTROL HEMATOCRIT CONTROL

    K Number: K121467 · Decision May 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    358

    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
    EUROTROL HEMATOCRIT CONTROL
    K Number
    K121467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurotrol B.V.
    Date Received
    May 17, 2012
    Decision Date
    May 10, 2013
    Product Code
    GLK
    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
    GLK Control, Hematocrit

    Similar 510(k) Clearances

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

    MEDICA EASYQC HEMATOCRIT CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMATACHEK

    FDA 510(k)
    FDA Class 2 ·Hematology

    CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4

    FDA 510(k)
    FDA Class 2 ·Hematology

    MSI-HCT

    FDA 510(k)
    FDA Class 2 ·Hematology

    A.QC HCT LEVEL 1 AND 2

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

    Other Clearances by Eurotrol B.V.

    K Number Device Name
    K192842 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
    K182744 HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
    K152553 CueSee Hypoxic
    K131595 EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
    K121468 EUROTROL GAS-ISE METABOLITES
    K060215 ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002