Cleared Traditional

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

K181464 · DiaSorin, Inc. · Microbiology
Aug 2018
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K181464 is an FDA 510(k) clearance for the LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on August 31, 2018, 88 days after receiving the submission on June 4, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K181464 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2018
Decision Date August 31, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110