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510(k) K011668

VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI by Oridion Medical 1987 , Ltd. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
May 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urea (Breath Or Blood)
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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