Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips

• 4 recalls, same reason

  • Terminated Z-2354-2008 FDA Unclassified (pre-2012) ·initiated 23 May 2008
  • Terminated Z-2355-2008 FDA Unclassified (pre-2012) ·initiated 23 May 2008
  • Terminated Z-2353-2008 FDA Unclassified (pre-2012) ·initiated 23 May 2008
  • Terminated Z-2352-2008 FDA Unclassified (pre-2012) ·initiated 23 May 2008

  Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results

510(k) Number

K003615 ↗

FDA Product Code

FKP

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sterichek Peracetic Acid Reagent Strips

  Class II

  FDA 510(k) K980164 Active Cleared 16 Apr 1998

• Sterichek Chlorine Reagent Strips

  Class II

  FDA 510(k) K971598 Active Cleared 18 Jul 1997

• Sterichek Total Chlorine Reagent Strips

  Class II

  FDA 510(k) K001194 Active Cleared 11 Jul 2000

• Sterichek Total Chlorine Test Kit

  Class II

  FDA 510(k) K983997 Active Cleared 2 Apr 1999

• Sterichek(Tm) Residual Peroxide Reagent Strps

  Class II

  FDA 510(k) K974798 Active Cleared 20 Mar 1998

• Sterichek Bicarb pH Reagent Strips

  Class II

  FDA 510(k) K031267 Active Cleared 23 Dec 2003

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