K190520 is an FDA 510(k) clearance for the VITROS XT Chemistry Products GLU-Ca Slides. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 3, 2019, 30 days after receiving the submission on March 4, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K190520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | April 03, 2019 |
| Days to Decision | 30 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 |