The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Gram Negative Ertapenem.
| Device ID | K041982 |
| 510k Number | K041982 |
| Device Name: | VITEK 2 GRAM NEGATIVE ERTAPENEM |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nancy Weaver |
| Correspondent | Nancy Weaver 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 | 2004-07-23 |
| Decision Date | 2004-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026424978 | K041982 | 000 |
| 03573026399047 | K041982 | 000 |
| 03573026399030 | K041982 | 000 |
| 03573026398996 | K041982 | 000 |
| 03573026408367 | K041982 | 000 |