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510(k) K161522

LIAISON EBV IgM Serum Control Set by DiaSorin, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2016
Date Received
June 2, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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