510(k) K163465 ยท GKR System, Hemoglobin, Automated
hemochroma PLUS System
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2017 |
| Received | Dec 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163465
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.