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

    SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT

    K Number: K812328 · Decision Sep 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    75
    Applicant Total
    9
    Review Days
    21

    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
    SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
    K Number
    K812328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Scripps-Miles, Inc.
    Date Received
    August 18, 1981
    Decision Date
    September 8, 1981
    Product Code
    DEW
    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
    DEW Igg, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    TINA-QUANT IGG GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPIFE IFE CALIBRATOR AND CONTROL KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    IGG

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

    Other Clearances by Scripps-Miles, Inc.

    K Number Device Name
    K812453 SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
    K811714 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
    K811433 SCRIPPSERA COMPLEMENT CONTROL SERA
    K810502 SCRIPPSYSTEM C4 RID KIT
    K810501 SCRIPPSYSTEM C3 RID KIT
    K810221 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
    K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
    K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA