K133343 is an FDA 510(k) clearance for the WONDFO RAPID STREP A TEST. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on January 31, 2014, 93 days after receiving the submission on October 30, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K133343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2013 |
| Decision Date | January 31, 2014 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |