The following data is part of a premarket notification filed by Becton, Dickinson & Company with the FDA for Bd Phoenix Automated Microbiology System - Gn Ceftazidime/avibactam (0.25/4- 32/4ug/ml).
| Device ID | K163637 |
| 510k Number | K163637 |
| Device Name: | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON, DICKINSON & COMPANY 7 LOVETON CIRCLE MC 694 Sparks, MD 21152 |
| Contact | Monica E. Giguere |
| Correspondent | Monica E. Giguere BECTON, DICKINSON & COMPANY 7 LOVETON CIRCLE MC 694 Sparks, MD 21152 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-03-21 |
| Summary: | summary |