Product code GSQ— Microbiology

CHOLERA SMART(TM)

Classification name
Antiserum, Vibrio Cholerae, All Varieties
Device class
Class 2
Regulation
21 CFR 866.3930
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

Market context for product code GSQ

FDA has cleared 3 devices under product code GSQ between 1992 and 1996, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code GSQ

Recent clearances under product code GSQ

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