The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Bactec Plus Prime Aerobic/f.
| Device ID | K120994 |
| 510k Number | K120994 |
| Device Name: | BD BACTEC PLUS PRIME AEROBIC/F |
| Classification | System, Blood Culturing |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks, MD 21152 |
| Contact | Paul Swift |
| Correspondent | Paul Swift Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks, MD 21152 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-08-07 |
| Summary: | summary |