K160370 is an FDA 510(k) clearance for the BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 9, 2016, 120 days after receiving the submission on February 10, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K160370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2016 |
| Decision Date | June 09, 2016 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |