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510(k) K030590

CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) by Hitachi Chemical Diagnostics, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2003
Date Received
February 25, 2003
Clearance Type
Special
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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