K230300 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, Calcium (Class II - Special Controls, product code JFP).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on October 27, 2023, 266 days after receiving the submission on February 3, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K230300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFP - Electrode, Ion Specific, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |