FDA Product Code GTY: Antigens, All Groups, Streptococcus Spp.

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 510(k) Review Time - GTY Product Code

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 →

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