Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
FDA 510(k) clearance K053110 · decided 2006-01-13
Clearance details
- K-number
- K053110
- Device name
- Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-11-04
- Decision date
- 2006-01-13
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Windsor, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. recall (Z-1846-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-05-27 |
| i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variet recall (Z-2022-2011) | Abbott Point Of Care Inc. | 2011-04-18 |
| i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro q recall (Z-1791-2010) | Abbott Point of Care Inc. | 2010-06-11 |