I-STAT CARDIAC TROPONIN (CTNI) TEST
FDA 510(k) clearance K031739 · decided 2003-09-02
Clearance details
- K-number
- K031739
- Device name
- I-STAT CARDIAC TROPONIN (CTNI) TEST
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-06-04
- Decision date
- 2003-09-02
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- 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 cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is a recall (Z-0716-2013) | Abbott Point of Care Canada Limited | 2013-01-24 |
| i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test recall (Z-2237-2012) | Abbott Point Of Care Inc. | 2012-08-22 |
| i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagn recall (Z-2169-2012) | Abbott Point Of Care Inc. | 2012-08-09 |
| i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of recall (Z-0180-2012) | Abbott Point Of Care Inc. | 2011-11-10 |