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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K162530
Device Name Multichem IA Plus
Applicant
Techno-Path Manufacturing
Ballina
Co. Tipperary,  IE
Applicant Contact BERND HASS
Correspondent
Techno-Path Manufacturing
Ballina
Co. Tipperary,  IE
Correspondent Contact BERND HASS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/09/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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