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510(k) K222167

E-Z Chek Chlorine Residual Test Strips (K100-0101B) by Reprocessing Products Corporation (Rpc) — Product Code MSY

K222167 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corporation (Rpc) for the device "E-Z Chek Chlorine Residual Test Strips (K100-0101B)". The FDA issued a decision of Substantially Equivalent on October 18, 2022. The device falls under product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant), a Class II device regulated under 21 CFR 876.5665. Reprocessing Products Corporation (Rpc) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2022
Date Received
July 21, 2022
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 Reprocessing Products Corporation (Rpc)

  • K132344 — E-Z CHECK OZONE TEST STRIPS (February 25, 2014)

Other clearances for product code MSY

  • K243898 — Chlorine Sentinel II (April 11, 2025)
  • 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