The following data is part of a premarket notification filed by Immunetics, Inc. with the FDA for Bacterial Detection Systems For Platelet Transfusion Products.
| Device ID | BK110054 |
| 510k Number | BK110054 |
| Device Name: | Bacterial Detection Systems For Platelet Transfusion Products |
| Classification | System, Detection, Bacterial, For Platelet Transfusion Products |
| Applicant | Immunetics, Inc. 27 Drydock Avenue Boston, MA 02210 |
| 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 | 2011-09-12 |
| Decision Date | 2012-06-11 |