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

    IMMUNOCHEMISTRY SYS. MANUAL MODE

    K Number: K781006 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    281
    Review Days
    73

    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
    IMMUNOCHEMISTRY SYS. MANUAL MODE
    K Number
    K781006
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4540
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    June 19, 1978
    Decision Date
    August 31, 1978
    Product Code
    JZW
    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
    JZW Nephelometer

    Similar 510(k) Clearances

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

    BN PROSPEC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Immunology

    BEHRING LASER NEPHELOMETER

    FDA 510(k)
    FDA Class 1 ·Immunology

    BEHRING NEPHELOMETER 100

    FDA 510(k)
    FDA Class 1 ·Immunology

    RRT SYSTEM LASER REFLECTOMETER ANALYZER

    FDA 510(k)
    FDA Class 1 ·Immunology

    TURBOX

    FDA 510(k)
    FDA Class 1 ·Immunology

    BCM-302 COLLIMATING CONE & COMPENSATIN

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

    Other Clearances by Beckman Instruments, Inc.

    K Number Device Name
    K973448 ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
    K982250 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    K981403 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
    K981354 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
    K980173 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
    K974816 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
    K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
    K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
    K974452 VIGIL LIPID CONTROL
    K973932 BECKMAN CALIBRATOR 2 (CAL2)
    Search all 281 clearances from Beckman Instruments, Inc. →