DeviceClearance

Product code KLJ— Clinical Chemistry

DETER. OF PHOSPHOHEXOSE ISOMERASE

Classification name
Nad Reduction (U.V.), Phosphohexose Isomerase
Device class
Class 1
Regulation
21 CFR 862.1570
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code KLJ

FDA has cleared 1 device under product code KLJ, 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 KLJ

Recent clearances under product code KLJ

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