DeviceClearance

Product code JXA— Microbiology

BAC-T-SCREEN

Classification name
Kit, Screening, Urine
Device class
Class 1
Regulation
21 CFR 866.2660
Advisory panel
Microbiology
Total cleared
44
First cleared
Most recent

Market context for product code JXA

FDA has cleared 44 devices under product code JXA between 1977 and 2001, filed by 34 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 JXA

Recent clearances under product code JXA

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