K830831 is an FDA 510(k) clearance for the AUTOMATED BLOOD CELL SEPARATOR. This device is classified as a Separator, Automated, Blood Cell And Plasma, Therapeutic.
Submitted by Cryosan, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 92 days after receiving the submission on March 16, 1983.
This device falls under the Hematology FDA review panel.
| 510(k) Number | K830831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1983 |
| Decision Date | June 16, 1983 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |