BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STAIN, R-250, COOMASSIE BRILLIANT BLUE

    K Number: K770718 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    92
    Review Days
    8

    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
    STAIN, R-250, COOMASSIE BRILLIANT BLUE
    K Number
    K770718
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4500
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    April 18, 1977
    Decision Date
    April 26, 1977
    Product Code
    JZS
    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
    JZS Electrophoresis Instrumentation

    Similar 510(k) Clearances

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

    SYNELISA TG ANTIBODIES/TPO ANTIBODIES

    FDA 510(k)
    FDA Class 1 ·Immunology

    IMMUNODIFFUSION BAND INTENSIFYING FLUID

    FDA 510(k)
    FDA Class 1 ·Immunology

    IMMUNOELECTROPHORESIS PROFILE KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    IMMUNOELECTROFILM KIH

    FDA 510(k)
    FDA Class 1 ·Immunology

    ELECTRO IMMUNO ASSAY KIT

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by Kallestad Laboratories, Inc.

    K Number Device Name
    K863681 PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
    K862917 PATHFINDER ROTAVIRUS CHEMILUMINESCENT
    K863682 PATHFINDER(TM) SPECIMEN COLLECTION KIT
    K862743 PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
    K862313 KALLESTAD SM/RNP TEST REAGENT
    K862710 KALLESTAD SSA/SSB ENA TEST REAGENTS
    K855014 QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
    K855010 QUANTIMETRIC PLUS IGM REAGENT KIT
    K855009 QUANTIMETRIC PLUS IGA REAGENT KIT
    K855008 QUANTIMETRIC PLUS KAPPA REAGENT KIT
    Search all 92 clearances from Kallestad Laboratories, Inc. →