Cleared Traditional

Curian HpSA, Curian Analyzer

K192817 · Meridian Bioscience, Inc. · Microbiology
Mar 2020
Decision
164d
Days
Class 1
Risk

About This 510(k) Submission

K192817 is an FDA 510(k) clearance for the Curian HpSA, Curian Analyzer, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 13, 2020, 164 days after receiving the submission on October 1, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K192817 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2019
Decision Date March 13, 2020
Days to Decision 164 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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