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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K162514
Device Name Multichem A1c
Applicant
Technopath Manufacturing
Fort Henry Business Park
Ballina,  IE
Applicant Contact Bernd Hass
Correspondent
Technopath Manufacturing
Fort Henry Business Park
Ballina,  IE
Correspondent Contact Bernd Hass
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/08/2016
Decision Date 10/26/2016
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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