K183205 is an FDA 510(k) clearance for the PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System. This device is classified as a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I - General Controls, product code JQC).
Submitted by Emcyte Corporation (Fort Meyers, US). The FDA issued a Cleared decision on May 30, 2019, 192 days after receiving the submission on November 19, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K183205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 19, 2018 |
| Decision Date | May 30, 2019 |
| Days to Decision | 192 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JQC - Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |