The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Phoenixtm Automated Microbiology System - Penicillin (strep) 0.156 -32 Ug/ml.
| Device ID | K050780 |
| 510k Number | K050780 |
| Device Name: | BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Contact | Linda Dillon |
| Correspondent | Linda Dillon BECTON DICKINSON & CO. 7 LOVETON CIR. 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 | 2005-03-28 |
| Decision Date | 2005-05-12 |
| Summary: | summary |