DeviceClearance

Product code JNO— Clinical Chemistry

AUTODELFIA NEONATAL IRT KIT

Classification name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Device class
Class 1
Regulation
21 CFR 862.1725
Advisory panel
Clinical Chemistry
Total cleared
7
First cleared
Most recent

Market context for product code JNO

FDA has cleared 7 devices under product code JNO between 1979 and 2011, filed by 7 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 JNO

Recent clearances under product code JNO

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