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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
510(k) Number K994226
Device Name STERICHEK TOTAL CHLORINE REAGENT STRIPS
Applicant
Environmental Test Systems, Inc.
23575 County Rd. 106
Elkhart,  IN  46514
Applicant Contact DAVID A MORRIS
Correspondent
Environmental Test Systems, Inc.
23575 County Rd. 106
Elkhart,  IN  46514
Correspondent Contact DAVID A MORRIS
Regulation Number876.5665
Classification Product Code
MSY  
Date Received12/15/1999
Decision Date 03/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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