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

    VARELISA RNP ANTIBODIES

    K Number: K993589 · Decision Nov 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    18
    Review Days
    35

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    Basic Information

    Device Name
    VARELISA RNP ANTIBODIES
    K Number
    K993589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia & Upjohn Co.
    Date Received
    October 22, 1999
    Decision Date
    November 26, 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 Pharmacia & Upjohn Co.

    K Number Device Name
    K003414 VARELISA TG (THYROGLOBULIN) ANTIBODIES,
    K002556 CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
    K000312 VARELISA SM ANTIBODIES
    K000132 ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
    K993585 VARELISA TPO ANTIBODIES, MODEL 12348/12396
    K993388 ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
    K993109 VARELISA RECOMBI ANA PROFILE
    K993108 VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
    K991945 PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
    K991048 ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2
    Search all 18 clearances from Pharmacia & Upjohn Co. →