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

    VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896

    K Number: K040451 · Decision May 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    81

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    Basic Information

    Device Name
    VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
    K Number
    K040451
    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
    February 20, 2004
    Decision Date
    May 11, 2004
    Product Code
    MSV
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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    Other Clearances by Pharmacia Deutschland GmbH

    K Number Device Name
    K041043 VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
    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
    K020758 VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
    K020757 VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
    K020752 VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596