DeviceClearance

Product code GMY— Microbiology

FLUORETEC-M

Classification name
Antisera, Fluorescent, All Types, Escherichia Coli
Device class
Class 1
Regulation
21 CFR 866.3255
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GMY

FDA has cleared 2 devices under product code GMY, all in 1977, filed by 2 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.

Top applicants under product code GMY

Recent clearances under product code GMY

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