K161837 is an FDA 510(k) clearance for the ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 16, 2016, 164 days after receiving the submission on July 5, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K161837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2016 |
| Decision Date | December 16, 2016 |
| Days to Decision | 164 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 |