The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Esbl Test.
| Device ID | K040845 |
| 510k Number | K040845 |
| Device Name: | VITEK 2 ESBL TEST |
| 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 | 2004-04-01 |
| Decision Date | 2004-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026628123 | K040845 | 000 |
| 03573026398507 | K040845 | 000 |
| 03573026398477 | K040845 | 000 |
| 03573026398460 | K040845 | 000 |
| 03573026398965 | K040845 | 000 |
| 03573026398453 | K040845 | 000 |
| 03573026398446 | K040845 | 000 |
| 03573026636333 | K040845 | 000 |
| 03573026636142 | K040845 | 000 |
| 03573026635978 | K040845 | 000 |
| 03573026636067 | K040845 | 000 |
| 03573026398972 | K040845 | 000 |
| 03573026398989 | K040845 | 000 |
| 03573026399016 | K040845 | 000 |
| 03573026426828 | K040845 | 000 |
| 03573026424985 | K040845 | 000 |
| 03573026408381 | K040845 | 000 |
| 03573026374556 | K040845 | 000 |
| 03573026144395 | K040845 | 000 |
| 03573026565923 | K040845 | 000 |
| 03573026427450 | K040845 | 000 |
| 03573026408374 | K040845 | 000 |
| 03573026398569 | K040845 | 000 |
| 03573026399023 | K040845 | 000 |
| 03573026636357 | K040845 | 000 |