CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
FDA 510(k) clearance K030768 · decided 2003-03-21
Clearance details
- K-number
- K030768
- Device name
- CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
- Applicant
- Cliniqa Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-03-11
- Decision date
- 2003-03-21
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JJT
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fallbrook, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot N recall (Z-0192-2013) | Abbott Point Of Care Inc. | 2012-11-02 |