K153357 is an FDA 510(k) clearance for the i-STAT Alinity System with i-STAT Sodium test. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on July 8, 2016, 231 days after receiving the submission on November 20, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K153357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2015 |
| Decision Date | July 08, 2016 |
| Days to Decision | 231 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 |