Cleared Traditional

PREMIER Platinum HpSA PLUS

K182559 · Meridian Bioscience, Inc. · Microbiology
Nov 2018
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K182559 is an FDA 510(k) clearance for the PREMIER Platinum HpSA PLUS, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 5, 2018, 49 days after receiving the submission on September 17, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K182559 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2018
Decision Date November 05, 2018
Days to Decision 49 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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