DeviceClearance

Product code CDW— Clinical Chemistry

UREA NITROGEN REAGENT SET

Classification name
Diacetyl-Monoxime, Urea Nitrogen
Device class
Class 2
Regulation
21 CFR 862.1770
Advisory panel
Clinical Chemistry
Total cleared
21
First cleared
Most recent

Market context for product code CDW

FDA has cleared 21 devices under product code CDW between 1976 and 1988, filed by 20 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

Top applicants under product code CDW

Recent clearances under product code CDW

Data sourced from openFDA. This site is unofficial and independent of the FDA.