The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phoenix Automated Microiology System- Ertapenem 0.0625-8 Ug/ml-gn.
| Device ID | K123266 |
| 510k Number | K123266 |
| Device Name: | BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks, MD 21152 |
| Contact | Monica E Giguere |
| Correspondent | Monica E Giguere Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 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 | 2012-10-19 |
| Decision Date | 2013-06-26 |
| Summary: | summary |