BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

    K Number: K103788 · Decision Nov 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    17
    Review Days
    316

    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
    PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
    K Number
    K103788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HORIBA ABX SAS
    Date Received
    December 27, 2010
    Decision Date
    November 8, 2011
    Product Code
    CFR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CFR Hexokinase, Glucose

    Similar 510(k) Clearances

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

    Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Glucose2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by HORIBA ABX SAS

    K Number Device Name
    K232946 Yumizen H2500
    K193649 Yumizen C1200 Creatinine PAP
    K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
    K192028 Yumizen C1200 CRP
    K191562 Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
    K191993 Yumizen C1200 CRP
    K191245 Yumizen C1200 ALP, Yumizen C1200 Albumin
    K191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
    K170353 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
    K151133 PENTRA XLR
    Search all 17 clearances from HORIBA ABX SAS →