Cleared Abbreviated

ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS

K120936 · Microgenics Corporation · Toxicology
Dec 2012
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K120936 is an FDA 510(k) clearance for the ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on December 13, 2012, 260 days after receiving the submission on March 28, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K120936 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2012
Decision Date December 13, 2012
Days to Decision 260 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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