The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Phoenix Automated Microbiology System.
| Device ID | K020321 |
| 510k Number | K020321 |
| Device Name: | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Bradford M Spring |
| Correspondent | Bradford M Spring 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 | 2002-01-15 |
| Decision Date | 2002-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902460115 | K020321 | 000 |
| 30382902460061 | K020321 | 000 |
| 30382902460047 | K020321 | 000 |
| 30382902460030 | K020321 | 000 |
| 00382902460169 | K020321 | 000 |
| 00382902460152 | K020321 | 000 |
| 00382904436247 | K020321 | 000 |