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

    PLATELET AGGREGATION REAGENT

    K Number: K850592 · Decision May 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    16
    Review Days
    87

    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
    PLATELET AGGREGATION REAGENT
    K Number
    K850592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Chrono-Log Corp.
    Date Received
    February 15, 1985
    Decision Date
    May 13, 1985
    Product Code
    JBX
    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
    JBX Aggregrometer, Platelet

    Similar 510(k) Clearances

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

    AGGRO/LINK CONTROL SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARACHIDONIC ACID

    FDA 510(k)
    FDA Class 2 ·Hematology

    PAT PLATELET AGGREGATION TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    ASSERACHROM B-TG KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    AGGRO/LINK COMPUTER INTERFACE

    FDA 510(k)
    FDA Class 2 ·Hematology

    RISTOCETIN PLATELET AGGREGA-REAGENT TEST

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

    Other Clearances by Chrono-Log Corp.

    K Number Device Name
    K161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
    K050265 CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
    K032951 CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
    K962426 CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
    K945414 RISTOCETIN COFACTOR ASSAY KIT
    K940792 AGGRO/LINK VW COFACTOR SOFTWARE
    K932566 AGGRO/LINK CONTROL SOFTWARE
    K922800 PLATELET AGGREGATION REAGENTS
    K851025 AGGRO/LINK COMPUTER INTERFACE
    K830749 PLATELET AGGREGOMETER
    Search all 16 clearances from Chrono-Log Corp. →