The following data is part of a premarket notification filed by Becton, Dickinson & Company with the FDA for Bacterial Detection Systems For Platelet Transfusion Products.
| Device ID | BK180211 |
| 510k Number | BK180211 |
| Device Name: | Bacterial Detection Systems For Platelet Transfusion Products |
| Classification | System, Detection, Bacterial, For Platelet Transfusion Products |
| Applicant | Becton, Dickinson & Company 7 Loveton Circle, Mc 694 Sparks, MD 21152 |
| Product Code | MZC |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-10 |
| Decision Date | 2018-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904420537 | BK180211 | 000 |