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510(k) K101750

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 by Reprocessing Products Corp — Product Code MNV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2011
Date Received
June 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Dialysate Ph Indicator
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • 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 MNV

  • K031267 — STERICHEK BICARB PH REAGENT STRIPS (December 23, 2003)
  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K944051 — ABSORBALBE ANCHOR (August 2, 1995)
  • K945491 — SERIM(TM) BICARB PH REAGENT STRIPS (February 1, 1995)