DeviceClearance

Product code JGY— Clinical Chemistry

BIOSCANNER TRIGLYCERIDES TEST STRIPS

Classification name
Colorimetric Method, Triglycerides
Device class
Class 1
Regulation
21 CFR 862.1705
Advisory panel
Clinical Chemistry
Total cleared
22
First cleared
Most recent

Market context for product code JGY

FDA has cleared 22 devices under product code JGY between 1977 and 2012, 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 JGY

Recent clearances under product code JGY

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