Product code GTC— Microbiology

SECURET DRAPE & INSTRUMENT RETAINER/INCL

Classification name
Antisera, All Types, Klebsiella Spp.
Device class
Class 1
Regulation
21 CFR 866.3340
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GTC

FDA has cleared 1 device under product code GTC, all in 1983, filed by 1 applicant company. 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 GTC

Recent clearances under product code GTC

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