ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620— 510(k) K071644

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K071644 for ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620, Substantially Equivalent on 2007-09-12. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DLZ
Advisory panel: Clinical Toxicology
Date received: 2007-06-15
Decision date: 2007-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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