Home / 510(k) Clearances / K043031

510(k) K043031

SERIM DIALYSATE MONITOR TEST STRIP by Serim Research Corp. — Product Code NTZ

K043031 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM DIALYSATE MONITOR TEST STRIP". The FDA issued a decision of Substantially Equivalent on June 13, 2005. The device falls under product code NTZ (Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator), a Class II device regulated under 21 CFR 876.5820. Serim Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2005
Date Received
November 3, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.

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)
  • K080712 — SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (May 6, 2008)
  • K052388 — SERIM PERACETIC ACID CHEMICAL INDICATOR (December 1, 2005)
  • K014038 — PYLORITEK VP TEST KIT 5140VP (February 8, 2002)

FDA data resources