THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY— 510(k) K122766
Substantially EquivalentMicrogenics Corp.
FDA 510(k) clearance K122766 for THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY, Substantially Equivalent on 2013-08-20. Applicant: Microgenics Corp.. Device class: 2.
Clearance details
- Applicant
- Microgenics Corp.
- Product code
- Code OUF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3840
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
Recent devices under product code OUF
view allMore clearances from Microgenics Corp.
view allRecalls naming K122766
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122766.
Data sourced from openFDA. This site is unofficial and independent of the FDA.