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

    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

    K Number: K090236 · Decision Apr 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    92
    Review Days
    84

    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
    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
    K Number
    K090236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics
    Date Received
    February 2, 2009
    Decision Date
    April 27, 2009
    Product Code
    LOJ
    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
    LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    Similar 510(k) Clearances

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

    Elecsys AFP

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS AFP

    FDA 510(k)
    FDA Class 2 ·Immunology

    OLYMPUS AFP - ALPHA-FETOPROTEIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIDAS AFP ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

    FDA 510(k)
    FDA Class 2 ·Immunology

    ST AIA-PACK AFP ENZYME IMMUNOASSAY

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

    Other Clearances by Siemens Healthcare Diagnostics

    K Number Device Name
    K243570 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
    K162977 ADVIA 2120i, ADVIA 2120
    K162298 LOCI Total Vitamin D Total Assay, LOCI VITD CAL
    K161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
    K162538 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
    K151964 Xprecia Stride Coagulation System, Xprecia System PT Controls
    K150168 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
    K143720 Dimension Vista MMB Assay
    K140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
    K150132 IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
    Search all 92 clearances from Siemens Healthcare Diagnostics →