The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Eurotrol Hematocrit Control.
| Device ID | K121467 |
| 510k Number | K121467 |
| Device Name: | EUROTROL HEMATOCRIT CONTROL |
| Classification | Control, Hematocrit |
| Applicant | EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Contact | Paul B.p. Kooijmans |
| Correspondent | Paul B.p. Kooijmans EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Product Code | GLK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-17 |
| Decision Date | 2013-05-10 |
| Summary: | summary |