Product code CDL— Clinical Chemistry
UREA NITROGEN TEST
- Classification name
- Berthelot Indophenol, Urea Nitrogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code CDL
FDA has cleared devices under product code CDL between 1976 and 1990, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1990
- 1989
- 1987
- 1986
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1976
Top applicants under product code CDL
Recent clearances under product code CDL
- K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
- K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
- K871651 — COLORIMETRIC BUN REAGENT KIT
- K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD
- K863889 — UREA NITROGEN TEST
- K863076 — UREAFAST
- K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET
- K831414 — COLORIMETRIC BUN
- K822237 — UREA NITROGEN REAGENT SET (MOD. BERTHEL
- K810261 — EUROCHIMA UREA NITROGEN
- K801727 — DATA-ZYME UREA NITROGEN, COLORIMETRIC
- K800902 — BUN-COLOR 2, BLOOD UREA NITROGEN TEST
- K792417 — ELVI BLOOD UREA NITROGEN
- K781899 — UREA NITROGEN TEST
- K781306 — UREA NITROGEN TEST KIT
- K761152 — S-UREA-N, IN VITRO DIAG FOR BUN
Data sourced from openFDA. This site is unofficial and independent of the FDA.