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

    HUMAN REFERENCE SERUM C4 COMPLEMENT

    K Number: K772003 · Decision Nov 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    56
    Review Days
    13

    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
    HUMAN REFERENCE SERUM C4 COMPLEMENT
    K Number
    K772003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    October 21, 1977
    Decision Date
    November 3, 1977
    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 G.D. Searle and Co.

    K Number Device Name
    K821159 IN-LINE OXYGEN MONITORING SYSTEM
    K811068 BYPASS COIL
    K811071 VENOUS OXYGEN PROBE
    K803238 INTRAVASCULAR CATHETER
    K810630 SILICONE ELASTOMER COATED LATEX FOLEY
    K810131 ADMINISTRATION SET
    K802485 SEARLE VASCULAR LOOPS
    K801805 METRONIDAZOLE DISCS
    K810112 SWR DISPOSABLE PREP RAZOR
    K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
    Search all 56 clearances from G.D. Searle and Co. →