K210958 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on August 13, 2021, 135 days after receiving the submission on March 31, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K210958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2021 |
| Decision Date | August 13, 2021 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |