The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Phoenix Automated Microbiology System-nitrofurantoin Gram Positive.
| Device ID | K031589 |
| 510k Number | K031589 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Michelle B Bandy |
| Correspondent | Michelle B Bandy 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 | 2003-05-21 |
| Decision Date | 2003-07-11 |
| Summary: | summary |