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

    COAG-I ANALYZER, ALPHA MODEL

    K Number: K882444 · Decision Aug 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    COAG-I ANALYZER, ALPHA MODEL
    K Number
    K882444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Diagnostic Services
    Date Received
    June 14, 1988
    Decision Date
    August 25, 1988
    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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