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

    URIC ACID RAPID STAT KIT

    K Number: K780827 · Decision Jun 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    10
    Review Days
    25

    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
    URIC ACID RAPID STAT KIT
    K Number
    K780827
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pierce Chemical Co.
    Date Received
    May 19, 1978
    Decision Date
    June 13, 1978
    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 Pierce Chemical Co.

    K Number Device Name
    K895661 GLYCOTEST II GLYHB ASSAY KIT
    K831837 CLINOVATIVE II DIAGNOSTIC KIT
    K821360 GLYCO-GEL TEST KIT
    K820279 GLYCO-GEL TEST KIT
    K781897 STAT KIT, MICROPROTEIN
    K780826 BILIRUBIN RAPID STAT KIT
    K780825 TRIGLYCERIDE C-37 RAPID STAT KIT
    K780512 AUTO/STAT KIT
    K780331 CHOLESTEROL RAPID SLAT KIT HDL