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510(k) K000578

SERIM LEUKOCYTE ESTERASE TEST STRIPS by Serim Research Corp. — Product Code LJX

K000578 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM LEUKOCYTE ESTERASE TEST STRIPS". The FDA issued a decision of Substantially Equivalent on May 5, 2000. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675. Serim Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2000
Date Received
February 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urine Leukocyte
Device Class
Class I
Regulation Number
864.7675
Review Panel
HE
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)
  • K080712 — SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (May 6, 2008)
  • K052388 — SERIM PERACETIC ACID CHEMICAL INDICATOR (December 1, 2005)
  • K043031 — SERIM DIALYSATE MONITOR TEST STRIP (June 13, 2005)

Other clearances for product code LJX

  • K231045 — Healgen URS Test Strips (June 16, 2023)
  • K063295 — ACON UTI URINARY TRACT INFECTION TEST STRIPS (October 12, 2007)
  • K981555 — DIASCREEN REAGENT STRIPS (June 1, 1998)
  • K971976 — DIASCREEN REAGENT STRIPS (June 17, 1997)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K843727 — LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (January 4, 1985)

FDA data resources