DeviceClearance

Product code JSS— Microbiology

E.COLI/P. AERUGINOSA PNA FISH

Classification name
Kit, Identification, Enterobacteriaceae
Device class
Class 1
Regulation
21 CFR 866.2660
Advisory panel
Microbiology
Total cleared
49
First cleared
Most recent

Market context for product code JSS

FDA has cleared 49 devices under product code JSS between 1976 and 2015, filed by 29 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 JSS

Recent clearances under product code JSS

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