K121467 is an FDA 510(k) clearance for the EUROTROL HEMATOCRIT CONTROL. This device is classified as a Control, Hematocrit (Class II - Special Controls, product code GLK).
Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on May 10, 2013, 358 days after receiving the submission on May 17, 2012.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K121467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2012 |
| Decision Date | May 10, 2013 |
| Days to Decision | 358 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GLK - Control, Hematocrit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |