K230285 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 Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on October 27, 2023, 267 days after receiving the submission on February 2, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K230285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHL - Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |