| Device ID | BK180274 |
| 510k Number | BK180274 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich, 63303, GM |
| Correspondent |
|
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
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| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-11 |
| Decision Date | 2019-03-21 |