The following data is part of a premarket notification filed by Diagnostica Stago with the FDA for Sta Liatest D-di.
| Device ID | K141144 |
| 510k Number | K141144 |
| Device Name: | STA LIATEST D-DI |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTICA STAGO PIAZZA ALBANIA 10 Italay, IT 00153 |
| Contact | Carlo D'alessandro |
| Correspondent | Carlo D'alessandro DIAGNOSTICA STAGO PIAZZA ALBANIA 10 Italay, 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 | 2014-05-02 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450005158 | K141144 | 000 |