510(k) K133343 ยท GTY Antigens, All Groups, Streptococcus Spp.
WONDFO RAPID STREP A TEST
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jan 31, 2014 |
| Received | Oct 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133343
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.