K163271 is an FDA 510(k) clearance for the i-Stat Alinity System with i-Stat Glucose test. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on April 10, 2017, 140 days after receiving the submission on November 21, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K163271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2016 |
| Decision Date | April 10, 2017 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |