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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Dialysate Ph Indicator
510(k) Number K031267
Device Name STERICHEK BICARB PH 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 Number876.5820
Classification Product Code
MNV  
Date Received04/21/2003
Decision Date 12/23/2003
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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