510(k) K160415 ยท GKF Instrument, Hematocrit, Automated
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Feb 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160415
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.