DeviceClearance

Product code JSY— Microbiology

API TB-IDENT*

Classification name
Kit, Identification, Mycobacteria
Device class
Class 1
Regulation
21 CFR 866.2660
Advisory panel
Microbiology
Total cleared
5
First cleared
Most recent

Market context for product code JSY

FDA has cleared 5 devices under product code JSY between 1983 and 1995, filed by 3 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 JSY

Recent clearances under product code JSY

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