The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas D-dimer Exclusion Ii (dex2).
| Device ID | K112818 |
| 510k Number | K112818 |
| Device Name: | VIDAS D-DIMER EXCLUSION II (DEX2) |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Veronica Daenzer |
| Correspondent | Veronica Daenzer BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-07-31 |
| Summary: | summary |