BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNELISA TG ANTIBODIES/TPO ANTIBODIES

    K Number: K933123 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    54
    Review Days
    56

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    Basic Information

    Device Name
    SYNELISA TG ANTIBODIES/TPO ANTIBODIES
    K Number
    K933123
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4500
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    June 28, 1993
    Decision Date
    August 23, 1993
    Product Code
    JZS
    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
    JZS Electrophoresis Instrumentation

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