DeviceClearance

Product code JIF— Clinical Chemistry

AMM

Classification name
Enzymatic Method, Ammonia
Device class
Class 1
Regulation
21 CFR 862.1065
Advisory panel
Clinical Chemistry
Total cleared
30
First cleared
Most recent

Market context for product code JIF

FDA has cleared 30 devices under product code JIF between 1976 and 2019, filed by 23 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code JIF

Recent clearances under product code JIF

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