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

    SERAQUEST RUBELLA IGM

    K Number: K982281 · Decision Oct 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    25
    Review Days
    108

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    Basic Information

    Device Name
    SERAQUEST RUBELLA IGM
    K Number
    K982281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Intl., Inc.
    Date Received
    June 30, 1998
    Decision Date
    October 16, 1998
    Product Code
    LFX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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