ROCHE ONLINE TDM PHENYTOIN— 510(k) K030428

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K030428 for ROCHE ONLINE TDM PHENYTOIN, Substantially Equivalent on 2003-04-28. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 2003-02-10
Decision date: 2003-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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