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

    DATA-ZYME URIC ACID PROCEDURE

    K Number: K831983 · Decision Aug 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    111
    Review Days
    49

    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
    DATA-ZYME URIC ACID PROCEDURE
    K Number
    K831983
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    June 20, 1983
    Decision Date
    August 8, 1983
    Product Code
    KNK
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNK Acid, Uric, Uricase (Colorimetric)

    Similar 510(k) Clearances

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

    URIC ACID MODEL 3P39

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITALAB URIC ACID REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Data Medical Associates, Inc.

    K Number Device Name
    K993098 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
    K971113 DMA TRIGLYCERIDES PROCEDURES
    K961919 DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
    K955302 SERUM BICARBONATE/CARBON DIOXIDE
    K955796 IRON CALIBRATOR & CALIBRATION VERIFICATION SET
    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
    K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    K946355 DMA ALBUMIN PROCEDURE
    Search all 111 clearances from Data Medical Associates, Inc. →