Cleared Traditional

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K161139 · DiaSorin, Inc. · Microbiology
Jul 2016
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K161139 is an FDA 510(k) clearance for the LIAISON H. pylori IgG, LIAISON H. pylori IgG 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 July 22, 2016, 91 days after receiving the submission on April 22, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K161139 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2016
Decision Date July 22, 2016
Days to Decision 91 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

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