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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 K971598
Device Name STERICHEK CHLORINE REAGENT STRIPS
Applicant
Environmental Test Systems, Inc.
23575 County Rd., #106
P.O.Box 4659
Elkhart,  IN  46514
Applicant Contact DAVID A MORRIS
Correspondent
Environmental Test Systems, Inc.
23575 County Rd., #106
P.O.Box 4659
Elkhart,  IN  46514
Correspondent Contact DAVID A MORRIS
Regulation Number876.5665
Classification Product Code
MSY  
Date Received05/01/1997
Decision Date 07/18/1997
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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