The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK220744 |
| 510k Number | BK220744 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles, 08150, SPAIN |
| 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 | 2022-07-12 |
| Decision Date | 2022-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436583730980 | BK220744 | 0 |