DeviceClearance

Product code JJG— Clinical Chemistry

ENCORE CHEMISTRY ANALYZER

Classification name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2140
Advisory panel
Clinical Chemistry
Total cleared
30
First cleared
Most recent

Market context for product code JJG

FDA has cleared 30 devices under product code JJG between 1977 and 1997, filed by 19 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 JJG

Recent clearances under product code JJG

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