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510(k) K151029

Phadia Prime by Phadia AB — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2016
Date Received
April 17, 2015
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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