Cleared Traditional

THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS

K100144 · Microgenics Corp. · Chemistry
Feb 2011
Decision
388d
Days
Class 2
Risk

About This 510(k) Submission

K100144 is an FDA 510(k) clearance for the THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS, a Everolimus Immunoassay (Class II — Special Controls, product code OUF), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on February 11, 2011, 388 days after receiving the submission on January 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3840.

Submission Details

510(k) Number K100144 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2010
Decision Date February 11, 2011
Days to Decision 388 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code OUF — Everolimus Immunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3840
Definition To Quantify Everolimus In Whole Blood.