The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK140101 |
| 510k Number | BK140101 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Manual Blood Grouping And Antibody Test Systems |
| Applicant | Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles, 08150, SP |
| Product Code | PBC |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-03 |
| Decision Date | 2014-05-21 |