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510(k) K974798

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS by Environmental Test Systems, Inc. — Product Code LIF

K974798 is an FDA 510(k) premarket notification submitted by Environmental Test Systems, Inc. for the device "STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS". The FDA issued a decision of Substantially Equivalent on March 20, 1998. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Environmental Test Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Environmental Test Systems, Inc.

  • K031267 — STERICHEK BICARB PH REAGENT STRIPS (December 23, 2003)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • 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)
  • K971598 — STERICHEK CHLORINE REAGENT STRIPS (July 18, 1997)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (May 14, 1997)

FDA data resources