The following data is part of a premarket notification filed by Diagnostica Stago with the FDA for Sta® - Liatest® D-di.
| Device ID | K162227 |
| 510k Number | K162227 |
| Device Name: | STA® - Liatest® D-Di |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | Diagnostica Stago 3, Allee Theresa Asnieres Sur Seine, FR 92600 |
| Contact | Arnaud Berthier |
| Correspondent | Carlo D'alessandro Donawa Lifescience Consulting Piazza Albania, 10 Rome, IT 00153 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2016-12-10 |
| Summary: | summary |