The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Hemotrol Duo Low, Hemotrol Duo Normal, Hemotrol Duo High.
| Device ID | K192842 |
| 510k Number | K192842 |
| Device Name: | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High |
| Classification | Control, Hemoglobin |
| Applicant | Eurotrol B.V. Keplerlaan 20 Ede, NL 6716bs |
| Contact | Elisanne Biemans |
| Correspondent | Elisanne Biemans Eurotrol B.V. Keplerlaan 20 Ede, NL 6716bs |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-03 |
| Decision Date | 2019-11-15 |