The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vtek 2 Ast-gn Ceftolozane/tazobactam (= 32 Mcg/ml).
| Device ID | K161510 |
| 510k Number | K161510 |
| Device Name: | VTEK 2 AST-GN Ceftolozane/Tazobactam (= 32 Mcg/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BIOMERIEUX, INC 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Cherece L. Jones |
| Correspondent | Cherece L. Jones BIOMERIEUX, INC 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LON |
| Subsequent Product Code | LTT |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2017-02-13 |
| Summary: | summary |