The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Nt-probnp Assay, Model: 30 449.
| Device ID | K073091 |
| 510k Number | K073091 |
| Device Name: | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nikita S Mapp |
| Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-02-29 |
| Summary: | summary |