K112377 is an FDA 510(k) clearance for the BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on March 23, 2012, 219 days after receiving the submission on August 17, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K112377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2011 |
| Decision Date | March 23, 2012 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |