The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Phoenix Automated Microbiology System-amoxicillin-clavulanate (gn) 0.5/0.25-32/16 Ug/ml, Ampicillin-sulbactam (gn) 0..
| Device ID | K061327 |
| 510k Number | K061327 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Vicki L Kennedy |
| Correspondent | Vicki L Kennedy BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-12 |
| Decision Date | 2006-07-03 |
| Summary: | summary |