The following data is part of a premarket notification filed by Diaspect Medical Gmbh with the FDA for Automated Hemoglobin System.
| Device ID | BK110036 |
| 510k Number | BK110036 |
| Device Name: | Automated Hemoglobin System |
| Classification | System, Hemoglobin, Automated |
| Applicant | Diaspect Medical GMBH 800 E. Leigh Street suite 206-5 Richmond, VA 23219 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2011-11-01 |