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510(k) K162961

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set by DiaSorin, Inc. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2017
Date Received
October 24, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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