BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIA REPTIN

    K Number: K841365 · Decision Jun 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    17
    Review Days
    60

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    Basic Information

    Device Name
    DIA REPTIN
    K Number
    K841365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diatech, Inc.
    Date Received
    April 2, 1984
    Decision Date
    June 1, 1984
    Product Code
    GIR
    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
    GIR Reagent, Russel Viper Venom

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    Other Clearances by Diatech, Inc.

    K Number Device Name
    K881685 FIBRINOGENTEST-O
    K854938 COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
    K854089 DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
    K854090 DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
    K842286 DIA T1, T2 & T3
    K841523 OWREN'S VERONAL BUFFERR
    K841462 HEPARIN COAGULATION CONTROL PLASMA 1-
    K841366 DIA FIBRIN
    K841461 COAGULATION CONTROL PLASMA LEVEL 1/2/3
    K840802 DIA THROMBIN DIA PLASTIN
    Search all 17 clearances from Diatech, Inc. →