K192150 is an FDA 510(k) clearance for the AMICUS Separator System. This device is classified as a Separator, Automated, Blood Cell And Plasma, Therapeutic.
Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on November 13, 2019, 96 days after receiving the submission on August 9, 2019.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K192150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2019 |
| Decision Date | November 13, 2019 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |