The following data is part of a premarket notification filed by Bd Diagnostic Systems with the FDA for Bd Phoenix Automated Microbiology System - Norfloxacin 0.25 - 16 Ug/ml.
| Device ID | K030091 |
| 510k Number | K030091 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BD DIAGNOSTIC SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Kathryn Babka Powers |
| Correspondent | Kathryn Babka Powers BD DIAGNOSTIC SYSTEMS 7 LOVETON CIRCLE 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 | 2003-01-10 |
| Decision Date | 2003-02-28 |
| Summary: | summary |