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

    AUTOSTAT II ANTI-SM/RNP ELISA

    K Number: K990624 · Decision Apr 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    31
    Review Days
    62

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    Basic Information

    Device Name
    AUTOSTAT II ANTI-SM/RNP ELISA
    K Number
    K990624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cogent Diagnotics , Ltd.
    Date Received
    February 25, 1999
    Decision Date
    April 28, 1999
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Cogent Diagnotics , Ltd.

    K Number Device Name
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    K993557 AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
    K994338 AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
    K993085 AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
    K993304 AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
    K992449 AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
    K993086 AUTOSTAT II ANTI-GLIADIN IGA ELISA
    K993087 AUTOSTAT II ANTI-GLIADIN IGG ELISA
    Search all 31 clearances from Cogent Diagnotics , Ltd. →