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

    DATA-ZYME UREA NITROGEN, COLORIMETRIC

    K Number: K801727 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    111
    Review Days
    47

    Basic Information

    Device Name
    DATA-ZYME UREA NITROGEN, COLORIMETRIC
    K Number
    K801727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    DATA MEDICAL ASSOCIATES, INC.
    Date Received
    July 24, 1980
    Decision Date
    September 9, 1980
    Product Code
    CDL
    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
    CDL Berthelot Indophenol, Urea Nitrogen

    Similar 510(k) Clearances

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

    RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLORIMETRIC BUN REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA NITROGEN(BUN), COLORIMETRIC METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA NITROGEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREAFAST

    FDA 510(k)
    FDA Class 2 ·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. →