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

    THERATEST EL-ANTI-CCP/2

    K Number: K090753 · Decision Mar 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    20
    Applicant Total
    22
    Review Days
    350

    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
    THERATEST EL-ANTI-CCP/2
    K Number
    K090753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theratest Laboratories, Inc.
    Date Received
    March 20, 2009
    Decision Date
    March 5, 2010
    Product Code
    NHX
    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
    NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

    Similar 510(k) Clearances

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

    ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULITE 2000 ANTI-CCP IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    MULTI-ANALYTE DETECTION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Immunology

    AXIS-SHIELD ANTI-CCP

    FDA 510(k)
    FDA Class 2 ·Immunology

    CCPOINT

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

    Other Clearances by Theratest Laboratories, Inc.

    K Number Device Name
    K090760 THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
    K071692 THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
    K061376 EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
    K060176 EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    K051066 THERATEST EL-ANA PROFILES
    K040291 EL-ANA PROFILES: ANTI-CHROMATIN
    K024031 THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
    K024151 EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
    K002559 EL-ANA PROFILES-2K1
    K982622 EL-ANA PROFILES: EL-ENA/5
    Search all 22 clearances from Theratest Laboratories, Inc. →