Cleared Traditional

ImmunoCard STAT! HpSA

K153661 · Meridian Bioscience, Inc. · Microbiology
Mar 2016
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K153661 is an FDA 510(k) clearance for the ImmunoCard STAT! HpSA, 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 14, 2016, 84 days after receiving the submission on December 21, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K153661 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date March 14, 2016
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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