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

    ELIAS CARDIOLIPIN IGM ANTIBODIES

    K Number: K933392 · Decision Dec 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    54
    Review Days
    149

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    Basic Information

    Device Name
    ELIAS CARDIOLIPIN IGM ANTIBODIES
    K Number
    K933392
    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
    July 12, 1993
    Decision Date
    December 8, 1993
    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 Elias U.S.A., Inc.

    K Number Device Name
    K964385 ELIAS ANA-HEP-2
    K963291 VARELISA ANA (4) PROFILE
    K953873 VARELISA HELICOBACTER PYLORI ANTIBODIES
    K953586 VARELISA PR3-ANCA
    K953587 VARELISA MPO-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
    Search all 54 clearances from Elias U.S.A., Inc. →