K220282 is an FDA 510(k) clearance for the i-STAT PTplus Cartridge with the i-STAT 1 System. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on July 14, 2023, 528 days after receiving the submission on February 1, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K220282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2022 |
| Decision Date | July 14, 2023 |
| Days to Decision | 528 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |