Medical Device Manufacturer · US , Cincinnati , OH

Meridian Bioscience, Inc. - FDA 510(k) Cleared Devices

38 submissions · 37 cleared · Since 2003

Recent clearances: Revogene, Premier HpSA Flex (619096), Curian® Shiga Toxin

Official Website

38

Total

37

Cleared

1

Denied

FDA 510(k) Regulatory Record - Meridian Bioscience, Inc. Microbiology ✕

38 devices

1-12 of 38

Cleared Mar 20, 2025

Microbiology · 90d

Cleared Jul 03, 2023

Premier HpSA Flex (619096)

Microbiology · 94d

Cleared Apr 17, 2023

Curian® Shiga Toxin

Microbiology · 210d

Cleared Jan 26, 2023

Microbiology · 134d

Cleared Jul 11, 2022

Microbiology · 143d

Cleared Dec 23, 2021

Microbiology · 266d

Cleared Mar 13, 2020

Curian HpSA, Curian Analyzer

Microbiology · 164d

Not Cleared Nov 30, 2018

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

DEN180040 · QDZ

Microbiology · 123d

Cleared Nov 05, 2018

PREMIER Platinum HpSA PLUS

Microbiology · 49d

Cleared Feb 21, 2017

Microbiology · 92d

Cleared Jun 13, 2016

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma...

Microbiology · 80d

Cleared Mar 14, 2016

ImmunoCard STAT! HpSA

Microbiology · 84d

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