K160495 is an FDA 510(k) clearance for the VITROS® Automation Solutions. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 18, 2016, 239 days after receiving the submission on February 22, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K160495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2016 |
| Decision Date | October 18, 2016 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |