FDA Product Code GTY: Antigens, All Groups, Streptococcus Spp.
Leading manufacturers include Healgen Scientific, LLC, ACON Laboratories, Inc. and Hangzhou AllTest Biotech Co., Ltd..
FDA 510(k) Cleared Antigens, All Groups, Streptococcus Spp. Devices (Product Code GTY)
About Product Code GTY - Regulatory Context
510(k) Submission Activity
44 total 510(k) submissions under product code GTY since 1981, with 44 receiving FDA clearance (average review time: 101 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GTY have taken an average of 132 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
GTY devices are reviewed by the Microbiology panel. Browse all Microbiology devices →