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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 K040920
Device Name AMYLASE LIQUID REAGENT, MODEL A532-200
Applicant
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact JIAN VAECHES
Correspondent
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact JIAN VAECHES
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received04/08/2004
Decision Date 05/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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