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

    AGGRO/LINK COMPUTER INTERFACE

    K Number: K851025 · Decision Jun 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    16
    Review Days
    93

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    Basic Information

    Device Name
    AGGRO/LINK COMPUTER INTERFACE
    K Number
    K851025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Chrono-Log Corp.
    Date Received
    March 11, 1985
    Decision Date
    June 12, 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

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    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
    K850592 PLATELET AGGREGATION REAGENT
    K830749 PLATELET AGGREGOMETER
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