Cleared Traditional

QMS LIDOCAINE CALIBRATORS, MODEL 0374678

K091617 · Thermo Fisher Scientific · Toxicology
Jul 2009
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K091617 is an FDA 510(k) clearance for the QMS LIDOCAINE CALIBRATORS, MODEL 0374678, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Thermo Fisher Scientific (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2009, 44 days after receiving the submission on June 3, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K091617 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2009
Decision Date July 17, 2009
Days to Decision 44 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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