FDA 510(k) Application Details - K043031

Device Classification Name	Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator   More FDA Info for this Device
510(K) Number	K043031
Device Name	Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
Applicant	SERIM RESEARCH CORP. 23565 REEDY DR. ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	PATRICIA A RUPCHOCK Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	NTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2004
Decision Date	06/13/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review