MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
FDA 510(k) clearance K894914 · decided 1989-10-16
Clearance details
- K-number
- K894914
- Device name
- MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
- Applicant
- I-Stat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-02
- Decision date
- 1989-10-16
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement recall (Z-1540-2009) | Abbott Point of Care Inc. | 2009-06-18 |
| Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500 recall (Z-0371-2008) | 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 |
| i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. recall (Z-1171-06) | Abbott Laboratories | 2006-06-22 |