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510(k) K183573

Vstrip H. pylori Antigen Rapid Test by Panion & BF Biotech, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
December 21, 2018
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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