Cleared Traditional

Premier HpSA Flex (619096)

K230901 · Meridian Bioscience, Inc. · Microbiology
Jul 2023
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K230901 is an FDA 510(k) clearance for the Premier HpSA Flex (619096), a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 3, 2023, 94 days after receiving the submission on March 31, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K230901 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date July 03, 2023
Days to Decision 94 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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