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510(k) K132344

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

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

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