The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Bactec Plus Aerobic/f Blood Culture Medium.
| Device ID | K083572 |
| 510k Number | K083572 |
| Device Name: | BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM |
| Classification | System, Blood Culturing |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Contact | Dennis Mertz |
| Correspondent | Dennis Mertz BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2008-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904421923 | K083572 | 000 |