I-STAT SYSTEM
FDA 510(k) clearance K973292 · decided 1997-10-20
Clearance details
- K-number
- K973292
- Device name
- I-STAT SYSTEM
- Applicant
- I-Stat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-02
- Decision date
- 1997-10-20
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- CGL
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| i-STAT Crea cartridge with the i-STAT 1 System (K261039) | Abbott Point of Care, Inc. | 2026-06-26 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point recall (Z-0456-2011) | Abbott Point of Care Inc. | 2010-11-24 |
| Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 3 recall (Z-0373-2008) | Abbott Point of Care Inc. | 2007-12-11 |