ROCHE ONLINE TDM QUINIDINE— 510(k) K032332

Name: FDA 510(k) clearance K032332
Creator: U.S. Food and Drug Administration
Published: 2004-01-12

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K032332 for ROCHE ONLINE TDM QUINIDINE, Substantially Equivalent on 2004-01-12. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LBZ
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2003-07-29
Decision date: 2004-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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