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510(k) K041238

HELICOBACTER PYLORI IGG ELISA by Biohit Plc — Product Code LYR

K041238 is an FDA 510(k) premarket notification submitted by Biohit Plc for the device "HELICOBACTER PYLORI IGG ELISA". The FDA issued a decision of Substantially Equivalent on December 13, 2004. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2004
Date Received
May 11, 2004
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

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  • 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)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK 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)

FDA data resources