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

    UREA NITROGEN (ENZYMATIC) DETERMINATION

    K Number: K822154 · Decision Aug 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    26
    Review Days
    13

    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
    UREA NITROGEN (ENZYMATIC) DETERMINATION
    K Number
    K822154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Dow Chemical Co.
    Date Received
    July 23, 1982
    Decision Date
    August 5, 1982
    Product Code
    CDN
    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
    CDN Urease, Photometric, Urea Nitrogen

    Similar 510(k) Clearances

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

    VITROS XT Chemistry Products UREA-CREA Slides

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by The Dow Chemical Co.

    K Number Device Name
    K823474 ENZYMATIC GLUCOSE DETERMINATION
    K821536 DOWFLOW ALT-UV DETERMINATION
    K821315 DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
    K820675 BILIRUBIN(TOTAL) DETERMINATION CTMS
    K820714 DOW BILIRUBIN(DIRECT) DETERMINATION
    K812777 DIRECT IRON REAGENT SET
    K811806 QUICK-CHEM COLORIMETER
    K810861 CREATINE KINASE MB ISOENZYME IMMUNO UV
    K810727 AST-UV (PLP-ACTIVATED) DETERMINATION
    K801501 UV URIC ACID STANDARDS
    Search all 26 clearances from The Dow Chemical Co. →