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510(k) K080712

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 by Serim Research Corp. — Product Code MSY

K080712 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM HISENSE ULTRA 0.1, PART NUMBER 5167". The FDA issued a decision of Substantially Equivalent on May 6, 2008. The device falls under product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant), a Class II device regulated under 21 CFR 876.5665. Serim Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2008
Date Received
March 13, 2008
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 Serim Research Corp.

  • K253863 — GUARDIAN™ Quick Dip Residual Chlorine (5212) (March 17, 2026)
  • K251035 — DISINTEK™ PA Test Strips (June 3, 2025)
  • K120652 — RAPICIDE OPA-28 TEST STRIP (October 12, 2012)
  • K092346 — SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 (January 7, 2010)
  • K083295 — SERIM DISINTEK GTA 2.1%, MODEL: 5164 (March 16, 2009)
  • K082352 — SERIM DISINTEK OPA TEST STRIP (September 25, 2008)
  • K081370 — SERIM DISINTEK OPA TEST STRIP (July 11, 2008)
  • K052388 — SERIM PERACETIC ACID CHEMICAL INDICATOR (December 1, 2005)
  • K043031 — SERIM DIALYSATE MONITOR TEST STRIP (June 13, 2005)
  • K014038 — PYLORITEK VP TEST KIT 5140VP (February 8, 2002)

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)
  • K002011 — GLUTARTEST 1 REAGENT STRIP (January 22, 2001)
  • 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