DeviceClearance

Product code JIN— Clinical Chemistry

ABBOTT BREATH ACETONE ANALYZER

Classification name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device class
Class 1
Regulation
21 CFR 862.1435
Advisory panel
Clinical Chemistry
Total cleared
24
First cleared
Most recent

Market context for product code JIN

FDA has cleared 24 devices under product code JIN between 1980 and 2020, 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

Top applicants under product code JIN

Recent clearances under product code JIN

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