BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

    K Number: K001981 · Decision Aug 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    2
    Review Days
    53

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    Basic Information

    Device Name
    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
    K Number
    K001981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Axis-Shield , Ltd.
    Date Received
    June 29, 2000
    Decision Date
    August 21, 2000
    Product Code
    MID
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MID System, Test, Anticardiolipin Immunological

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    Other Clearances by Axis-Shield , Ltd.

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