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510(k) K031267

STERICHEK BICARB PH REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code MNV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
April 21, 2003
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

Other clearances by Environmental Test Systems, Inc.

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  • 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)
  • K980164 — STERICHEK PERACETIC ACID REAGENT STRIPS (April 16, 1998)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)
  • K971598 — STERICHEK CHLORINE REAGENT STRIPS (July 18, 1997)

Other clearances for product code MNV

  • 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)
  • 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)