Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

38 results for "Meridian Bioscience, Inc."
1–24 of 38
Cleared Mar 20, 2025
Revogene
K243922 · OOI
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Jul 03, 2023
Premier HpSA Flex (619096)
K230901 · LYR
Meridian Bioscience, Inc.
Microbiology · 94d
Cleared Apr 17, 2023
Curian® Shiga Toxin
K222829 · GMZ
Meridian Bioscience, Inc.
Microbiology · 210d
Cleared Jan 26, 2023
Revogene
K222779 · OOI
Meridian Bioscience, Inc.
Microbiology · 134d
Cleared Jul 11, 2022
Revogene
K220480 · OOI
Meridian Bioscience, Inc.
Microbiology · 143d
Cleared Dec 23, 2021
Curian Campy
K210976 · LQP
Meridian Bioscience, Inc.
Microbiology · 266d
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817 · LYR
Meridian Bioscience, Inc.
Microbiology · 164d
Not Cleared Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
DEN180040 · QDZ
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Nov 05, 2018
PREMIER Platinum HpSA PLUS
K182559 · LYR
Meridian Bioscience, Inc.
Microbiology · 49d
Cleared Feb 21, 2017
TRU Legionella
K163273 · MJH
Meridian Bioscience, Inc.
Microbiology · 92d
Cleared Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma...
K160829 · OZX
Meridian Bioscience, Inc.
Microbiology · 80d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661 · LYR
Meridian Bioscience, Inc.
Microbiology · 84d
Cleared Nov 10, 2015
illumigene Pertussis DNA Amplification Assay
K152285 · OZZ
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800 · OZX
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Jul 17, 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External...
K151046 · PGI
Meridian Bioscience, Inc.
Microbiology · 88d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL...
K133673 · OZZ
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Jan 03, 2014
TRU FLU
K133714 · PSZ
Meridian Bioscience, Inc.
Microbiology · 29d
Cleared Jun 05, 2013
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA...
K123423 · OZX
Meridian Bioscience, Inc.
Microbiology · 211d
Cleared Sep 13, 2012
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
K122019 · OYZ
Meridian Bioscience, Inc.
Microbiology · 65d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · NJR
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190 · MJH
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048 · MCB
Meridian Bioscience, Inc.
Microbiology · 151d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · NJR
Meridian Bioscience, Inc.
Microbiology · 133d
Cleared May 03, 2011
PREMIER C. DIFFICILE GDH
K110620 · MCB
Meridian Bioscience, Inc.
Microbiology · 61d