510(k) K122766
- Device
- THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
- Applicant
- MICROGENICS CORP.
- 510(k) number
- K122766
- Product code
- OUF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-20
- Date received
- 2012-09-10
- Regulation
- 862.3840
- Classification name
- Everolimus Immunoassay
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN LEE
- Address
- 46360 Fremont Blvd. Fremont Blvd. CA US 94538 94538
FDA Registration Numbers#
- 3010939897
- 2517506
Source Documents#
Other 510(k) Records For Product Code OUF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | Microgenics Corp. | 2011-02-11 |
Legacy Summary#
summary
FDA Review#
Decision Summary