K230275 is an FDA 510(k) clearance for the i-STAT CG8+ cartridge with the i-STAT 1 System. 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 October 27, 2023, 268 days after receiving the submission on February 1, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K230275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 268 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 |