The following data is part of a premarket notification filed by Diagast with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK190313 |
| 510k Number | BK190313 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | DIAGAST parc Eurasanté 251, Avenue Eugéne Avinée Loos Cedex, 59374, FR |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2020-05-07 |