Cleared Traditional

QMS LIDOCAINE

K090282 · Thermo Fisher Scientific, Inc. · Toxicology

May 2009

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K090282 is an FDA 510(k) clearance for the QMS LIDOCAINE, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Thermo Fisher Scientific, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 29, 2009, 113 days after receiving the submission on February 5, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number	K090282 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2009
Decision Date	May 29, 2009
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement