Cleared Traditional

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY

K122766 · Microgenics Corp. · Chemistry
Aug 2013
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K122766 is an FDA 510(k) clearance for the THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY, a Everolimus Immunoassay (Class II — Special Controls, product code OUF), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on August 20, 2013, 344 days after receiving the submission on September 10, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3840.

Submission Details

510(k) Number K122766 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2012
Decision Date August 20, 2013
Days to Decision 344 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.