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510(k) K132801

IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY by Siemens Healthcare Diagnostics, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
September 13, 2013
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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