The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Gram Negative Levofloxacin.
| Device ID | K072038 |
| 510k Number | K072038 |
| Device Name: | VITEK 2 GRAM NEGATIVE LEVOFLOXACIN |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Jolyn Tenliado |
| Correspondent | Jolyn Tenliado BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-25 |
| Decision Date | 2007-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026617752 | K072038 | 000 |
| 03573026636319 | K072038 | 000 |
| 03573026636128 | K072038 | 000 |
| 03573026636067 | K072038 | 000 |
| 03573026636081 | K072038 | 000 |
| 03573026636104 | K072038 | 000 |
| 03573026634797 | K072038 | 000 |
| 03573026398491 | K072038 | 000 |
| 03573026608132 | K072038 | 000 |
| 03573026636296 | K072038 | 000 |