BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

    K Number: K041043 · Decision Jul 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    71

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    Basic Information

    Device Name
    VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
    K Number
    K041043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia Deutschland GmbH
    Date Received
    April 22, 2004
    Decision Date
    July 2, 2004
    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 Pharmacia Deutschland GmbH

    K Number Device Name
    K040810 VARELISA HISTONE ANTIBODIES, MODEL 16496
    K040811 VARELISA SSDNA ANTIBODIES, MODEL 14896
    K040449 VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
    K040450 VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
    K040452 VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
    K040451 VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
    K020758 VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
    K020757 VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
    K020752 VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596