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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K122858
Device Name ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
Applicant
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1070
Classification Product Code
JFJ  
Subsequent Product Codes
JIX   JJY  
Date Received09/18/2012
Decision Date 10/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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