VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI— 510(k) K011668

Substantially Equivalent

Oridion Medical 1987 , Ltd.

FDA 510(k) clearance K011668 for VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI, Substantially Equivalent on 2001-07-09. Applicant: Oridion Medical 1987 , Ltd..

Clearance details

Applicant: Oridion Medical 1987 , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2001-05-17
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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