DeviceClearance

Product code LFP— Clinical Chemistry

BUN REAGENT KIT

Classification name
Conductivity Rate, Urea Nitrogen
Device class
Class 2
Regulation
21 CFR 862.1770
Advisory panel
Clinical Chemistry
Total cleared
6
First cleared
Most recent

Market context for product code LFP

FDA has cleared 6 devices under product code LFP between 1981 and 2000, filed by 6 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 LFP

Recent clearances under product code LFP

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