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510(k) K132344

E-Z CHECK OZONE TEST STRIPS by Reprocessing Products Corporation (Rpc) — Product Code MSY

K132344 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corporation (Rpc) for the device "E-Z CHECK OZONE TEST STRIPS". The FDA issued a decision of Substantially Equivalent on February 25, 2014. 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
February 25, 2014
Date Received
July 29, 2013
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)

  • K222167 — E-Z Chek Chlorine Residual Test Strips (K100-0101B) (October 18, 2022)

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)
  • 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