Medical Device Manufacturer · US , Cincinnati , OH

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

38 submissions · 37 cleared · Since 2003

Total

Cleared

Denied

Meridian Bioscience, Inc. has 37 FDA 510(k) cleared microbiology devices. Based in Cincinnati, US.

Latest FDA clearance: Mar 2025. Active since 2003.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Meridian Bioscience, Inc.

38 devices

1-12 of 38

Premier HpSA Flex (619096)

Curian HpSA, Curian Analyzer

K192817 · LYR

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

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

K160829 · OZX

Microbiology · 80d

Cleared Mar 14, 2016

ImmunoCard STAT! HpSA

K153661 · LYR

Microbiology · 84d

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

FDA 510(k) cleared devices by Meridian Bioscience, Inc.

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