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 Ceftaroline (0.0156-4 µg/ml).
| Device ID | K190905 |
| 510k Number | K190905 |
| Device Name: | BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/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 | 2019-04-08 |
| Decision Date | 2019-07-01 |