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510(k) K110745

HELICOBACTER PYLORI ELISA IGG TEST KIT by Gold Standard Diagnostics — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2012
Date Received
March 17, 2011
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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