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

    KIT, PLATELET AGGREGATION REAGENT (#390)

    K Number: K760198 · Decision Jul 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    13

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    Basic Information

    Device Name
    KIT, PLATELET AGGREGATION REAGENT (#390)
    K Number
    K760198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Chrono-Log Corp.
    Date Received
    July 6, 1976
    Decision Date
    July 19, 1976
    Product Code
    GHR
    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
    GHR Reagent, Platelet Aggregation

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    Other Clearances by Chrono-Log Corp.

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    K962426 CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
    K945414 RISTOCETIN COFACTOR ASSAY KIT
    K940792 AGGRO/LINK VW COFACTOR SOFTWARE
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    K922800 PLATELET AGGREGATION REAGENTS
    K851025 AGGRO/LINK COMPUTER INTERFACE
    K850592 PLATELET AGGREGATION REAGENT
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