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510(k) K161139

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set by DiaSorin, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2016
Date Received
April 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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