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

    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

    K Number: K020758 · Decision May 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    10
    Review Days
    56

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
    K Number
    K020758
    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
    March 7, 2002
    Decision Date
    May 2, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MID), ordered by most recent decision date.

    Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 2200 APLS IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    K040451 VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
    K020757 VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
    K020752 VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596