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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, Bicarbonate, Glucose, Acid, Indicator
510(k) Number K043031
Device Name SERIM DIALYSATE MONITOR TEST STRIP
Applicant
Serim Research Corp.
23565 Reedy Dr.
Elkhart,  IN  46514
Applicant Contact PATRICIA A RUPCHOCK
Correspondent
Serim Research Corp.
23565 Reedy Dr.
Elkhart,  IN  46514
Correspondent Contact PATRICIA A RUPCHOCK
Regulation Number876.5820
Classification Product Code
NTZ  
Date Received11/03/2004
Decision Date 06/13/2005
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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