i-STAT CG4+ cartridge with the i-STAT 1 System
FDA 510(k) clearance K244014 · decided 2025-05-02
Clearance details
- K-number
- K244014
- Device name
- i-STAT CG4+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-26
- Decision date
- 2025-05-02
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-STAT CG4+ cartridge (white). List Number: 03P85-25. recall (Z-2582-2025) | Abbott Point Of Care Inc. | 2025-09-17 |