K183680 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. This device is classified as a Device, Hematocrit Measuring (Class II - Special Controls, product code JPI).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 28, 2020, 427 days after receiving the submission on December 28, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K183680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2018 |
| Decision Date | February 28, 2020 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPI - Device, Hematocrit Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |