510(k) K182298 ยท GKR System, Hemoglobin, Automated
hemochroma PLUS System
| Applicant | Immunostics Inc.,, Eatontown NJ, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Aug 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182298
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.