K160415 is an FDA 510(k) clearance for the GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation). This device is classified as a Instrument, Hematocrit, Automated (Class II - Special Controls, product code GKF).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 14, 2016, 306 days after receiving the submission on February 12, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.5600.
| 510(k) Number | K160415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2016 |
| Decision Date | December 14, 2016 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | GKF — Instrument, Hematocrit, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5600 |