ONLINE DAT PROPOXYPHENE PLUS— 510(k) K043303

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043303 for ONLINE DAT PROPOXYPHENE PLUS, Substantially Equivalent on 2005-03-11. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JXN
Advisory panel: Clinical Toxicology
Date received: 2004-11-30
Decision date: 2005-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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