The following data is part of a premarket notification filed by Haemonetics Manufacturing Inc. with the FDA for Bacterial Detection Systems For Platelet Transfusion Products.
| Device ID | BK070063 |
| 510k Number | BK070063 |
| Device Name: | Bacterial Detection Systems For Platelet Transfusion Products |
| Classification | System, Detection, Bacterial, For Platelet Transfusion Products |
| Applicant | Haemonetics Manufacturing Inc. 400 Wood Road Braintree, MA 02184 |
| Product Code | MZC |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-12 |
| Decision Date | 2008-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887691306373 | BK070063 | 0 |