The following data is part of a premarket notification filed by Bio-rad Medical Diagnostics Gmbh with the FDA for System, Test, Automated Blood Grouping And Antibody.
| Device ID | BK200548 |
| 510k Number | BK200548 |
| Device Name: | System, Test, Automated Blood Grouping And Antibody |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich, 63303, GERMANY |
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-01-13 |