510(k) K162333 ยท KHE Reagent, Occult Blood
Wondfo One Step Fecal Occult Blood (FOB) Test
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, May 14, 2017 |
| Received | Aug 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162333
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.