The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/ml).
| Device ID | K132909 |
| 510k Number | K132909 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE MC 614 Sparks, MD 21152 |
| Contact | Katie Coyle |
| Correspondent | Katie Coyle 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 | 2013-09-17 |
| Decision Date | 2014-02-14 |
| Summary: | summary |