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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K161527
Device Name Teco Creatinine Enzymatic Reagent Kit
Applicant
Teco Diagnostics, Inc.
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact XIAOYAN HU
Correspondent
Teco Diagnostics, Inc.
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact XIAOYAN HU
Regulation Number862.1225
Classification Product Code
JFY  
Date Received06/02/2016
Decision Date 07/21/2017
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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