The following data is part of a premarket notification filed by Emcyte Corporation with the FDA for Purebmc Supraphysiologic Concentrating System 30 Ml System, Purebmc Supraphysiologic Concentrating System 60 Ml System, Purebmc Supraphysiologic Concentrating System 120 Ml System.
| Device ID | K183205 |
| 510k Number | K183205 |
| Device Name: | PureBMC SupraPhysiologic Concentrating System 30 ML System, PureBMC SupraPhysiologic Concentrating System 60 ML System, PureBMC SupraPhysiologic Concentrating System 120 ML System |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | EmCyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Myers, FL 33916 |
| Contact | Patrick Pennie |
| Correspondent | Patrick Pennie EmCyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Myers, FL 33916 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-05-30 |