K140690 is an FDA 510(k) clearance for the BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER. This device is classified as a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II - Special Controls, product code CDQ).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 2, 2014, 167 days after receiving the submission on March 19, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K140690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2014 |
| Decision Date | September 02, 2014 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |