GTY
- Product code
- GTY
- Device name
- Antigens, All Groups, Streptococcus Spp.
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.3740
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 44 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260342 | 2026-04-30 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Strep A Rapid Test | |
| K251697 | 2025-11-26 | ACON Laboratories, Inc. | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex | — |
Official FDA classification page: GTY
Classification and pathway per current FDA publications. Data from openFDA (CC0).