Cleared Traditional

THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS

K123343 · Microgenics Corp. · Toxicology
Jul 2013
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K123343 is an FDA 510(k) clearance for the THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on July 11, 2013, 253 days after receiving the submission on October 31, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K123343 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2012
Decision Date July 11, 2013
Days to Decision 253 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MLM — Enzyme Immunoassay, Tracrolimus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1678

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