ONLINE TDM PROCAINAMIDE— 510(k) K060773

Name: FDA 510(k) clearance K060773
Creator: U.S. Food and Drug Administration
Published: 2006-08-23

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060773 for ONLINE TDM PROCAINAMIDE, Substantially Equivalent on 2006-08-23. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LAR
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2006-03-22
Decision date: 2006-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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