The following data is part of a premarket notification filed by Bio-rad Medical Diagnostics Gmbh with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK220769 |
| 510k Number | BK220769 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich, 63303, GERMANY |
| Product Code | MMH |
| CFR Regulation Number | 864.9165 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-12-07 |