Wondfo Rapid Strep a Test
FDA 510(k) K133343 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK133343
Submission
- Device name
- Wondfo Rapid Strep a Test
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- October 30, 2013
- Decision date
- January 31, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/30/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | ACON Laboratories, Inc. | 11/26/2025SE |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab)GTY · Traditional | Healgen Scientific,, LLC | 03/16/2022SE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track | Quidel Corporation | 12/21/2017SE |
| K141775 | Sofia (R) Strep A+ FiaGTY · Dual Track | Quidel Corporation | 12/16/2014SE |
| K123793 | Sofia Strep a FiaGTY · Traditional | Quidel Corporation | 06/17/2013SE |
| K122718 | BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional | Becton, Dickinson and Company | 02/06/2013SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | Binax, Inc. | 09/04/2009SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | Princeton BioMeditech Corp. | 10/06/2008SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | Unipath , Ltd. | 12/06/2005SE |
More from Unipath , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | 04/28/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | 11/18/2025SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | 10/22/2025SE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional | 09/30/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | 07/16/2024SE |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT · Traditional | 09/25/2020SE |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test CupNFT · Traditional | 12/03/2018SE |
| K173229 | Preview Digital Pregnancy TestLCX · Traditional | 03/12/2018SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | 05/14/2017SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | 06/27/2016SE |
Questions and answers
When was Wondfo Rapid Strep a Test cleared by the FDA?
Wondfo Rapid Strep a Test (K133343) received a 510(k) decision of Substantially Equivalent on January 31, 2014, 93 days after the submission was received.
What is the product code of K133343?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.