The following data is part of a premarket notification filed by Emcyte Corporation with the FDA for Platelet Separation/concentration System.
| Device ID | BK190317 |
| 510k Number | BK190317 |
| Device Name: | Platelet Separation/Concentration System |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | EmCyte Corporation 4331 Veronica South Shoemaker Blvd For Myers, FL 33916 US |
| 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 | 2019-02-11 |
| Decision Date | 2020-02-12 |