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510(k) K090338

ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE by Reprocessing Products Corp — Product Code MSY

K090338 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corp for the device "ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE". The FDA issued a decision of Substantially Equivalent on May 8, 2009. 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 Corp has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2009
Date Received
February 10, 2009
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 Corp

  • K123805 — E-Z CHEK BLOOD LEAK TEST STRIPS (March 20, 2013)
  • K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST S (January 7, 2011)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974064 — MICRO X RESIDUAL TEST STRIPS (December 7, 1998)
  • K950602 — PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (November 30, 1995)

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)
  • 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