510(k) K032332— ROCHE ONLINE TDM QUINIDINE

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

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

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