The following data is part of a premarket notification filed by Becton,dickinson And Company with the FDA for Bd Phoenix Automated Microbiology System - Bd Phoenix Cpo Detect - Gn.
| Device ID | K181665 |
| 510k Number | K181665 |
| Device Name: | BD Phoenix Automated Microbiology System - BD Phoenix CPO Detect - GN |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Becton,Dickinson And Company 7 Loveton Circle MC 694 Sparks, MD 21152 |
| Contact | Monica E. Giguere |
| Correspondent | Monica E. Giguere 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 | 2018-06-25 |
| Decision Date | 2018-09-21 |
| Summary: | summary |