The following data is part of a premarket notification filed by Becton, Dickinson And Co. with the FDA for Bd Phoenix Automated Microbiology System-pipercillin (gn) 0.5-128 Ug/ml.
| Device ID | K041572 |
| 510k Number | K041572 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON, DICKINSON AND CO. 7 LOVETON CIRCLE Sparks, MD |
| Contact | Monica E Giguere |
| Correspondent | Monica E Giguere BECTON, DICKINSON AND CO. 7 LOVETON CIRCLE Sparks, MD |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-08-12 |
| Summary: | summary |