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

    ELECSYS IGE II IMMUNOASSAY

    K Number: K061970 · Decision Aug 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    183
    Review Days
    50

    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
    ELECSYS IGE II IMMUNOASSAY
    K Number
    K061970
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    July 12, 2006
    Decision Date
    August 31, 2006
    Product Code
    JHR
    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
    JHR Radioimmunoassay, Immunoglobulins (D, E)

    Similar 510(k) Clearances

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

    ELECYS IGE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMILITE TOTAL IGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULITE TOTAL IGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    TURBO-RAST SPECIFIC IGE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

    FDA 510(k)
    FDA Class 2 ·Immunology

    ALTERNATE PROCEDURE, PHARMACIA IGE EIA

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

    Other Clearances by Roche Diagnostics

    K Number Device Name
    K252323 cobas pulse blood glucose monitoring system
    K252280 Elecsys Anti-SARS-CoV-2 S
    K260048 Elecsys Anti-HAV IgM
    K260049 Elecsys Anti-HBc IgM
    K260046 Elecsys Anti-HBc II
    K260026 Tina-quant Cardiac high sensitivity CRP III
    K253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
    K253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
    K253839 Elecsys Anti-SARS-CoV-2
    K253188 CoaguChek XS Plus System
    Search all 183 clearances from Roche Diagnostics →