FDA Product Code GTY: Antigens, All Groups, Streptococcus Spp.
Leading manufacturers include Healgen Scientific, LLC and ACON Laboratories, Inc..
2
Total
2
Cleared
194d
Avg days
2022
Since
List of Antigens, All Groups, Streptococcus Spp. devices cleared through 510(k)
2 devices
Cleared
Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
ACON Laboratories, Inc.
Microbiology
177d
Cleared
Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
Healgen Scientific, LLC
Microbiology
210d
How to use this database
This page lists all FDA 510(k) submissions for Antigens, All Groups, Streptococcus Spp. devices (product code GTY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →