OPTIGEN ALLERGEN SPECIFIC IGE ASSAY— 510(k) K051677

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K051677 for OPTIGEN ALLERGEN SPECIFIC IGE ASSAY, Substantially Equivalent on 2006-01-23. Applicant: Hitachi Chemical Diagnostics, Inc..

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code DHB
Advisory panel: Immunology
Date received: 2005-06-21
Decision date: 2006-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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