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510(k) K051677

OPTIGEN ALLERGEN SPECIFIC IGE ASSAY by Hitachi Chemical Diagnostics, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2006
Date Received
June 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

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