i-STAT CG4+ cartridge with the i-STAT 1 System — Abbott Point of Care, Inc. (510(k) K244014)
i-STAT CG4+ cartridge with the i-STAT 1 System — Abbott Point of Care, Inc. (510(k) K244014) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: i-STAT CG4+ cartridge with the i-STAT 1 System; Applicant: Abbott Point of Care, Inc.; Clearance track: 510(k).
| Device name | i-STAT CG4+ cartridge with the i-STAT 1 System |
|---|---|
| Applicant | Abbott Point of Care, Inc. |
| Clearance track | 510(k) |
| Submission number | K244014 |
| Decision | Substantially Equivalent |
| Decision date | 2025-05-02 |
| Date received | 2024-12-26 |
| Product code | CHL |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | NJ, US |
| Source | openFDA device |
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