K072018 is an FDA 510(k) clearance for the BS-200 CHEMISTRY ANALYZER, MODE BS-200. 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 February 1, 2008, 193 days after receiving the submission on July 23, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K072018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2007 |
| Decision Date | February 01, 2008 |
| Days to Decision | 193 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 |