The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Rapid Strep A Test.
| Device ID | K133343 |
| 510k Number | K133343 |
| Device Name: | WONDFO RAPID STREP A TEST |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-30 |
| Decision Date | 2014-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816862021056 | K133343 | 000 |
| 10850253007748 | K133343 | 000 |
| 10850253007731 | K133343 | 000 |
| 10816862023586 | K133343 | 000 |
| 10816862023722 | K133343 | 000 |