DeviceClearance

Product code JKG— Clinical Chemistry

REAGENT SYSTEM 153-UV

Classification name
L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
Device class
Class 1
Regulation
21 CFR 862.1420
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code JKG

FDA has cleared 1 device under product code JKG, all in 1977, filed by 1 applicant company. 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.

Top applicants under product code JKG

Recent clearances under product code JKG

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