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

    GAMMA CLQ

    K Number: K823009 · Decision Nov 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    24

    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
    GAMMA CLQ
    K Number
    K823009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Medical Products, Inc.
    Date Received
    October 12, 1982
    Decision Date
    November 5, 1982
    Product Code
    DAK
    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
    DAK Complement C1q, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    BINDAZYME CLQ CIC EIA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    IBL C1Q-CIC CIA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    CIC-C1Q EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMUSTRIP HAMA IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

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

    Other Clearances by Gamma Medical Products, Inc.

    K Number Device Name
    K833275 GMP CIQ ELISA TEST KIT