I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
FDA 510(k) clearance K001154 · decided 2000-04-18
Clearance details
- K-number
- K001154
- Device name
- I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
- Applicant
- I-Stat Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-10
- Decision date
- 2000-04-18
- Days to decision
- 8 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, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; P recall (Z-0370-2008) | Abbott Point of Care Inc. | 2007-12-11 |
| Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 1 recall (Z-0372-2008) | Abbott Point of Care Inc. | 2007-12-11 |
| Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: recall (Z-0374-2008) | Abbott Point of Care Inc. | 2007-12-11 |
| Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 12010 recall (Z-0375-2008) | Abbott Point of Care Inc. | 2007-12-11 |