Home / 510(k) Clearances / K014038

510(k) K014038

PYLORITEK VP TEST KIT 5140VP by Serim Research Corp. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2002
Date Received
December 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Serim Research Corp.

  • 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)
  • K012115 — SERIM BLOOD LEAK TEST STRIP-2 (November 30, 2001)

Other clearances for product code LYR

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)