The following data is part of a premarket notification filed by Perfusion Partners & Associates, Inc. with the FDA for Platelet Separation/concentration System.
| Device ID | BK050055 |
| 510k Number | BK050055 |
| Device Name: | Platelet Separation/Concentration System |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | Perfusion Partners & Associates, Inc. 6227 Foxfire Lane Fort Myers, FL 33912 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-22 |
| Decision Date | 2006-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855306003725 | BK050055 | 0 |
| 00855306003312 | BK050055 | 0 |
| 00855306003305 | BK050055 | 0 |
| 00855306003299 | BK050055 | 0 |
| 00855306003190 | BK050055 | 0 |
| 00855306003183 | BK050055 | 0 |
| 00855306003084 | BK050055 | 0 |
| 00855306003053 | BK050055 | 0 |
| 00855306003046 | BK050055 | 0 |
| 00855306003039 | BK050055 | 0 |
| 00855306003022 | BK050055 | 0 |
| 00855306003015 | BK050055 | 0 |
| 00855306003329 | BK050055 | 0 |
| 00855306003381 | BK050055 | 0 |
| 00855306003404 | BK050055 | 0 |
| 00855306003718 | BK050055 | 0 |
| 00855306003701 | BK050055 | 0 |
| 00855306003695 | BK050055 | 0 |
| 00855306003688 | BK050055 | 0 |
| 00855306003510 | BK050055 | 0 |
| 00855306003503 | BK050055 | 0 |
| 00855306003459 | BK050055 | 0 |
| 00855306003442 | BK050055 | 0 |
| 00855306003435 | BK050055 | 0 |
| 00855306003428 | BK050055 | 0 |
| 00855306003411 | BK050055 | 0 |
| 00855306003008 | BK050055 | 0 |