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510(k) K980164

STERICHEK PERACETIC ACID REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code MSY

K980164 is an FDA 510(k) premarket notification submitted by Environmental Test Systems, Inc. for the device "STERICHEK PERACETIC ACID REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on April 16, 1998. The device falls under product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant), a Class II device regulated under 21 CFR 876.5665. Environmental Test Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1998
Date Received
January 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class
Class II
Regulation Number
876.5665
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)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)
  • K971598 — STERICHEK CHLORINE REAGENT STRIPS (July 18, 1997)

Other clearances for product code MSY

  • K243898 — Chlorine Sentinel II (April 11, 2025)
  • K222167 — E-Z Chek Chlorine Residual Test Strips (K100-0101B) (October 18, 2022)
  • K193169 — Nelson Sentinel Series Basic Chlorine Sentinel (October 29, 2020)
  • K132344 — E-Z CHECK OZONE TEST STRIPS (February 25, 2014)
  • K090338 — ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (May 8, 2009)
  • K080712 — SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (May 6, 2008)
  • K002011 — GLUTARTEST 1 REAGENT STRIP (January 22, 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)

FDA data resources