THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
FDA 510(k) clearance K110616 · decided 2011-06-29
Clearance details
- K-number
- K110616
- Device name
- THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-03
- Decision date
- 2011-06-29
- Days to decision
- 118 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 Omni Immune Controls recall (Z-1929-2014) | Microgenics Corporation | 2014-06-26 |
| MAS Omni Immune PRO Controls recall (Z-1930-2014) | Microgenics Corporation | 2014-06-26 |
| Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoass recall (Z-0379-2013) | Microgenics Corporation | 2012-11-19 |