AMPHETAMINES II ASSAY— 510(k) K093664

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K093664 for AMPHETAMINES II ASSAY, Substantially Equivalent on 2010-07-28. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2009-11-27
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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