Cleared Traditional

ROCHE ONLINE TDM LIDOCAINE

K032334 · Roche Diagnostics Corp. · Chemistry
Jan 2004
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K032334 is an FDA 510(k) clearance for the ROCHE ONLINE TDM LIDOCAINE, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2004, 167 days after receiving the submission on July 29, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number K032334 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2003
Decision Date January 12, 2004
Days to Decision 167 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KLR — Enzyme Immunoassay, Lidocaine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3555

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