K191360 is an FDA 510(k) clearance for the i-STAT CHEM8+ 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 February 14, 2020, 269 days after receiving the submission on May 21, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K191360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2019 |
| Decision Date | February 14, 2020 |
| Days to Decision | 269 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 |