The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Virtuo Microbial Detection System, Bact/alert Virtuo, Virtuo.
| Device ID | K161816 |
| 510k Number | K161816 |
| Device Name: | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO |
| Classification | System, Blood Culturing |
| Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Jolyn Tenllado |
| Correspondent | Jolyn Tenllado bioMerieux, Inc. 595 Anglum Rd. 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 | 2016-07-01 |
| Decision Date | 2017-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026614546 | K161816 | 000 |
| 03573026369774 | K161816 | 000 |
| 03573026369767 | K161816 | 000 |
| 03573026629649 | K161816 | 000 |