DeviceClearance

Product code JSI— Microbiology

HEKTOEN ENTERIC AGAR

Classification name
Culture Media, Selective And Differential
Device class
Class 1
Regulation
21 CFR 866.2360
Advisory panel
Microbiology
Total cleared
285
First cleared
Most recent

Market context for product code JSI

FDA has cleared 285 devices under product code JSI between 1977 and 2007, filed by 46 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 JSI

Recent clearances under product code JSI

1–100 of 285

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