Home / 510(k) Clearances / K052716

510(k) K052716

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT by Otsuka Pharmaceutical Co., Ltd. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2006
Date Received
September 29, 2005
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 Otsuka Pharmaceutical Co., Ltd.

  • K092817 — POC-AS10 AUTO SAMPLER (March 9, 2010)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)
  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K001032 — RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (July 24, 2000)
  • K991083 — RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (August 20, 1999)

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)