Submission Details
| 510(k) Number | K160495 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS? Automation Solutions
Oct 2016
Decision
239d
Days
Class 2
Risk
About This 510(k) Submission
K160495 is an FDA 510(k) clearance for the VITROS? Automation Solutions, 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 review panel. Regulated under 21 CFR 862.1700.
Device Classification
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1700 |
Manufacturer
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