K162462 is an FDA 510(k) clearance for the AMICUS Separator System, AMICUS Separator System; Refurbished. This device is classified as a Separator, Automated, Blood Cell, Diagnostic (Class II - Special Controls, product code GKT).
Submitted by Fresenius Kabi USA,Llc (Lake Zurich, US). The FDA issued a Cleared decision on November 23, 2016, 82 days after receiving the submission on September 2, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9245.
| 510(k) Number | K162462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2016 |
| Decision Date | November 23, 2016 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKT — Separator, Automated, Blood Cell, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9245 |