Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

38 results for "Meridian Bioscience, Inc."
1–24 of 38
Search insights Median review: 94d Cleared: 97% Top manufacturer: Meridian Bioscience, Inc. Lead specialty: Microbiology
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 CT 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