The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK190318 |
| 510k Number | BK190318 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles, 08150, SP |
| 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 | 2019-02-12 |
| Decision Date | 2019-12-10 |