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510(k) K002011

GLUTARTEST 1 REAGENT STRIP by Integrated Biomedical Technology, Inc. — Product Code MSY

K002011 is an FDA 510(k) premarket notification submitted by Integrated Biomedical Technology, Inc. for the device "GLUTARTEST 1 REAGENT STRIP". The FDA issued a decision of Substantially Equivalent on January 22, 2001. The device falls under product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant), a Class II device regulated under 21 CFR 876.5665. Integrated Biomedical Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2001
Date Received
July 3, 2000
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 Integrated Biomedical Technology, Inc.

  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)

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

FDA data resources