K163433 is an FDA 510(k) clearance for the VITROS Chemistry Products GLU Slides. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 18, 2017, 285 days after receiving the submission on December 7, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K163433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2016 |
| Decision Date | September 18, 2017 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |