The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for System, Detection, Baterial, For Platelet Transfusion Products.
| Device ID | BK050043 |
| 510k Number | BK050043 |
| Device Name: | System, Detection, Baterial, For Platelet Transfusion Products |
| Classification | System, Detection, Bacterial, For Platelet Transfusion Products |
| Applicant | bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712 US |
| 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 | 2005-07-14 |
| Decision Date | 2005-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026126735 | BK050043 | 000 |