K160585 is an FDA 510(k) clearance for the XN CAL. This device is classified as a Calibrator For Cell Indices (Class II - Special Controls, product code KRX).
Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on December 22, 2016, 296 days after receiving the submission on March 1, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8150.
| 510(k) Number | K160585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KRX — Calibrator For Cell Indices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8150 |