THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
FDA 510(k) clearance K122766 · decided 2013-08-20
Clearance details
- K-number
- K122766
- Device name
- THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-10
- Decision date
- 2013-08-20
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- OUF
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont Blvd., CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS (K100144) | Microgenics Corp. | 2011-02-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 ( recall (Z-0008-2017) | Microgenics Corporation | 2016-10-03 |