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510(k) K974064

MICRO X RESIDUAL TEST STRIPS by Reprocessing Products Corp — Product Code MSY

K974064 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corp for the device "MICRO X RESIDUAL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on December 7, 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. Reprocessing Products Corp has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1998
Date Received
October 27, 1997
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)
  • K090338 — ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (May 8, 2009)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • 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)
  • 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