K200530 is an FDA 510(k) clearance for the AMICUS Separator System. This device is classified as a Separator, Automated, Blood Cell, Diagnostic (Class II - Special Controls, product code GKT).
Submitted by Fresenius Kabi AG (Lake Zurich, US). The FDA issued a Cleared decision on September 11, 2020, 193 days after receiving the submission on March 2, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 864.9245.
| 510(k) Number | K200530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | September 11, 2020 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GKT — Separator, Automated, Blood Cell, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9245 |