The following data is part of a premarket notification filed by Becton, Dickinson, And Company with the FDA for Bd Phoenix Automated Microbiology System - Gn Ceftolozane/tazobactam (0.25/4-32/4 Ug/ml).
| Device ID | K173252 |
| 510k Number | K173252 |
| Device Name: | BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 Ug/mL) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Becton, Dickinson, And Company 7 Loveton Circle MC 694 Sparks, MD 21152 |
| Contact | Laura Stewart |
| Correspondent | Laura Stewart Becton, Dickinson, And 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 | 2017-10-10 |
| Decision Date | 2018-01-05 |
| Summary: | summary |