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510(k) K992255

CKHEMO, MODEL CKHEMO VERSION 1.0 by Csam, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1999
Date Received
July 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
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  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)