DeviceClearance

Product code JFS— Clinical Chemistry

CHLORIDE REAGENT KIT

Classification name
Coulometric, Chloride
Device class
Class 2
Regulation
21 CFR 862.1170
Advisory panel
Clinical Chemistry
Total cleared
19
First cleared
Most recent

Market context for product code JFS

FDA has cleared 19 devices under product code JFS between 1976 and 2013, filed by 13 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 JFS

Recent clearances under product code JFS

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