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510(k) K041238

HELICOBACTER PYLORI IGG ELISA by Biohit Plc — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2004
Date Received
May 11, 2004
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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