The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Bactec Plus Aerobic/f (plastic).
| Device ID | K113558 |
| 510k Number | K113558 |
| Device Name: | BD BACTEC PLUS AEROBIC/F (PLASTIC) |
| Classification | System, Blood Culturing |
| Applicant | Becton, Dickinson And Company 7 LOVETON CIRCLE MC 614 Sparks, MD 21043 |
| Contact | Paul Swift |
| Correspondent | Paul Swift Becton, Dickinson And Company 7 LOVETON CIRCLE MC 614 Sparks, MD 21043 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904420230 | K113558 | 000 |