K120765 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS ECO2 SLIDES. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 24, 2012, 225 days after receiving the submission on March 13, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K120765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2012 |
| Decision Date | October 24, 2012 |
| Days to Decision | 225 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |