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510(k) K200279

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine by Phadia AB — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2020
Date Received
February 4, 2020
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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