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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 K001194
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  
Subsequent Product Code
MSZ  
Date Received04/12/2000
Decision Date 07/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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