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

    VARELISA MPO-ANCA

    K Number: K953587 · Decision Jan 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    54
    Review Days
    178

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    Basic Information

    Device Name
    VARELISA MPO-ANCA
    K Number
    K953587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    August 1, 1995
    Decision Date
    January 26, 1996
    Product Code
    MOB
    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
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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    Other Clearances by Elias U.S.A., Inc.

    K Number Device Name
    K964385 ELIAS ANA-HEP-2
    K963291 VARELISA ANA (4) PROFILE
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    K953586 VARELISA PR3-ANCA
    K951187 VARELISA CARDIOLIPIN ABS SCREEN
    K951205 VARELISA ANA PROFILE
    K951206 VARELISA PARIETAL CELL ANTIBODIES
    K951207 VARELISA HISTONE ANTIBODIES
    K944334 VARELISA COMBINED DNA ANTIBODIES EIA
    K951186 VARELISA ANA-4 SCREEN
    Search all 54 clearances from Elias U.S.A., Inc. →