The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Mp Reagent System.
| Device ID | K190405 |
| 510k Number | K190405 |
| Device Name: | BACT/ALERT MP Reagent System |
| Classification | System, Blood Culturing |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Esther Hernandez |
| Correspondent | Esther Hernandez 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 | 2019-02-19 |
| Decision Date | 2019-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026611798 | K190405 | 000 |
| 03573026428853 | K190405 | 000 |