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510(k) K043031

SERIM DIALYSATE MONITOR TEST STRIP by Serim Research Corp. — Product Code NTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2005
Date Received
November 3, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.

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