Home / 510(k) Clearances / K243898

510(k) K243898

Chlorine Sentinel II by Nelson Environmental Technologies, Inc. — Product Code MSY

K243898 is an FDA 510(k) premarket notification submitted by Nelson Environmental Technologies, Inc. for the device "Chlorine Sentinel II". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant), a Class II device regulated under 21 CFR 876.5665. Nelson Environmental Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2025
Date Received
December 19, 2024
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 Nelson Environmental Technologies, Inc.

  • K193169 — Nelson Sentinel Series Basic Chlorine Sentinel (October 29, 2020)
  • K993877 — NELSON WATER SYSTEMS FOR HEMODIALYSIS (May 25, 2000)

Other clearances for product code MSY

  • 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)
  • K974064 — MICRO X RESIDUAL TEST STRIPS (December 7, 1998)

FDA data resources