CARDIOIMMUNE XL CARDIAC MARKER CONTROL
FDA 510(k) clearance K061196 · decided 2006-05-30
Clearance details
- K-number
- K061196
- Device name
- CARDIOIMMUNE XL CARDIAC MARKER CONTROL
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-28
- Decision date
- 2006-05-30
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fremont Blvd., CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinic recall (Z-0501-2015) | Microgenics Corporation | 2014-12-04 |
| ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Ma recall (Z-0637-2012) | Microgenics Corporation | 2012-01-11 |