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

    CA-1000 AUTOMATED COAGULATION ANALYZER

    K Number: K931149 · Decision Nov 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    33
    Review Days
    240

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    Basic Information

    Device Name
    CA-1000 AUTOMATED COAGULATION ANALYZER
    K Number
    K931149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    March 8, 1993
    Decision Date
    November 3, 1993
    Product Code
    JPA
    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
    JPA System, Multipurpose For In Vitro Coagulation Studies

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    Other Clearances by Toa Medical Electronics USA, Inc.

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    K912494 SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
    K911172 SYSMEX F-610
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