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510(k) K003615

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
November 22, 2000
Clearance Type
Special
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

Other clearances by Environmental Test Systems, Inc.

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  • K001194 — STERICHEK TOTAL CHLORINE REAGENT STRIPS (July 11, 2000)
  • K994226 — STERICHEK TOTAL CHLORINE REAGENT STRIPS (March 22, 2000)
  • K983997 — STERICHEK TOTAL CHLORINE TEST KIT (April 2, 1999)
  • K980164 — STERICHEK PERACETIC ACID REAGENT STRIPS (April 16, 1998)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)
  • K971598 — STERICHEK CHLORINE REAGENT STRIPS (July 18, 1997)

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  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)