DeviceClearance

Product code JQB— Clinical Chemistry

ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST

Classification name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Device class
Class 1
Regulation
21 CFR 862.1360
Advisory panel
Clinical Chemistry
Total cleared
52
First cleared
Most recent

Market context for product code JQB

FDA has cleared 52 devices under product code JQB between 1976 and 1997, filed by 33 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 JQB

Recent clearances under product code JQB

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