510(k) K191147 ยท OOX Automated Occult Blood Analyzer
OC-Auto SENSOR io iFOB Test
| Applicant | Eiken Chemical Co., Ltd., Taito-Ku, JP |
| Decision | Substantially Equivalent, Jan 2, 2020 |
| Received | Apr 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191147
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.