The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Fa Plus; Bact/alert Pf Plus.
| Device ID | K183166 |
| 510k Number | K183166 |
| Device Name: | BacT/ALERT FA Plus; BacT/ALERT PF Plus |
| Classification | System, Blood Culturing |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Mary Beth Anheuser |
| Correspondent | Mary Beth Anheuser bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-02-11 |
| Summary: | summary |