I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
FDA 510(k) clearance K031873 · decided 2003-10-07
Clearance details
- K-number
- K031873
- Device name
- I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-06-17
- Decision date
- 2003-10-07
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- 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 |
|---|---|---|
| Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level recall (Z-1863-2011) | Abbott Point Of Care Inc. | 2011-04-01 |
| Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to recall (Z-1864-2011) | Abbott Point Of Care Inc. | 2011-04-01 |