THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS— 510(k) K100144

Name: FDA 510(k) clearance K100144
Creator: U.S. Food and Drug Administration
Published: 2011-02-11

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K100144 for THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS, Substantially Equivalent on 2011-02-11. 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: 2010-01-19
Decision date: 2011-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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