GTY — Antigens, All Groups, Streptococcus Spp. Class I
FDA product code GTY covers "Antigens, All Groups, Streptococcus Spp.", a Class I medical device regulated under 21 CFR 866.3740. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GTY
- Device Class
- Class I
- Regulation Number
- 866.3740
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260342 | hangzhou alltest biotech co | AllTest Strep A Rapid Test | April 30, 2026 |
| K251697 | acon laboratories | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St | November 26, 2025 |
| K212623 | healgen scientific | Healgen Strep A Rapid Test Strip (Throat Swab) | March 16, 2022 |
| K171976 | quidel corporation | Sofia Strep A+ FIA, Sofia 2 Analyzer | December 21, 2017 |
| K141775 | quidel corporation | SOFIA (R) STREP A+ FIA | December 16, 2014 |
| K133343 | guangzhou wondfo biotech co | WONDFO RAPID STREP A TEST | January 31, 2014 |
| K123793 | quidel corporation | SOFIA STREP A FIA | June 17, 2013 |
| K122718 | becton, dickinson and | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP | February 6, 2013 |
| K091489 | binax | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | September 4, 2009 |
| K082661 | princeton biomeditech | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | October 6, 2008 |
| K051638 | unipath | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | December 6, 2005 |
| K040708 | princeton biomeditech | STATUS FIRST STREP A | November 22, 2004 |
| K031784 | acon laboratories | ACON STREP A RAPID TEST DEVICE | July 14, 2003 |
| K023766 | acon laboratories | ACON STREP A TWIST TEST DEVICE | February 10, 2003 |
| K023270 | sa scientific | SAS STREPALERT | October 17, 2002 |
| K013379 | sa scientific | SAS STREPALERT | December 12, 2001 |
| K011097 | quidel | QUICKVUE DIPSTICK STREP A | May 8, 2001 |
| K010582 | acon laboratories | ACON STREP A RAPID TEST STRIP | May 7, 2001 |
| K993456 | sa scientific | SAS STREP A TEST | March 7, 2000 |
| K992658 | wyntek diagnostics | OSOM ULTRA STREP A TEST, MODEL 147 | January 18, 2000 |