Meridian Bioscience, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Meridian Bioscience, Inc.” (first 2003, latest 2025), plus 1 PMA and 1 De Novo decisions, across 18 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 134 days, against 120 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 65 |
| 2013 | 1 | 211 |
| 2014 | 2 | 72 |
| 2015 | 3 | 88 |
| 2016 | 2 | 82 |
| 2017 | 1 | 92 |
| 2018 | 1 | 49 |
| 2019 | 0 | — |
| 2020 | 1 | 164 |
| 2021 | 1 | 266 |
| 2022 | 1 | 143 |
| 2023 | 3 | 134 |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Meridian Bioscience, Inc. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYR | Helicobacter Pylori | 6 | 6 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 | 4 |
| GMZ | Antigens, All Types, Escherichia Coli | 3 | 3 |
| LQP | Campylobacter Spp. | 3 | 3 |
| OOI | Real Time Nucleic Acid Amplification System | 3 | 3 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | 3 | 3 |
| MCB | Antigen, C. Difficile | 2 | 2 |
| MJH | Legionella, Spp., Elisa | 2 | 2 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 2 | 2 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 2 | 2 |
Plus 8 more product codes.
Review panels
- Microbiology (36)
- Clinical Chemistry (3)
Most recent Meridian Bioscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243922 | Revogene | OOI | 2025-03-20 | 90 |
| K230901 | Premier HpSA Flex (619096) | LYR | 2023-07-03 | 94 |
| K222829 | Curian® Shiga Toxin | GMZ | 2023-04-17 | 210 |
| K222779 | Revogene | OOI | 2023-01-26 | 134 |
| K220480 | Revogene | OOI | 2022-07-11 | 143 |
| K210976 | Curian Campy | LQP | 2021-12-23 | 266 |
| K192817 | Curian HpSA, Curian Analyzer | LYR | 2020-03-13 | 164 |
| K182559 | PREMIER Platinum HpSA PLUS | LYR | 2018-11-05 | 49 |
| K163273 | TRU Legionella | MJH | 2017-02-21 | 92 |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | OZX | 2016-06-13 | 80 |
27 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180040 | De Novo | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | 2018-11-30 |
| P100025 | PMA | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | 2012-02-22 |
Recalls
22 product recalls in 16 recall events; 9 initiated in the last five years. Most recent: 2025-12-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Meridian Bioscience, Inc. is the lead sponsor of 16 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03611101: Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials (Completed, started 2018-05-04)
- NCT03422341: Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs. (Completed, started 2018-02-14)
- NCT03251261: Detection of Cytomegalovirus Virus in Neonates (Completed, started 2017-08-02)
- NCT02905825: Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics (Completed, started 2017-05-18)
- NCT02968758: Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains (Completed, started 2017-02-06)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Meridian Bioscience, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Meridian Diagnostics, Inc. (92 510(k)s)
- Meridian Medical Systems, LLC (8 510(k)s)
- Meridian Co., Ltd. (7 510(k)s)
- Meridian AG (6 510(k)s)
- Meridian Medical Technologies, Inc. (6 510(k)s)
- Meridian Bioscience Israel , Ltd. (3 510(k)s)
- Meridian Dynamics Biomedical, Inc. (1 510(k)s)
- Meridian Medical (1 510(k)s)
- Meridian Technique, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meridian Bioscience, Inc.?
FDA lists 37 510(k) clearances under the applicant name “Meridian Bioscience, Inc.” (first 2003, latest 2025), plus 1 PMA and 1 De Novo decisions, across 18 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Meridian Bioscience, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meridian Bioscience, Inc. is 94 days. Since 2017: 134 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Meridian Bioscience, Inc.?
The most frequent FDA product codes under this applicant name are LYR (Helicobacter Pylori, 6); PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 4); GMZ (Antigens, All Types, Escherichia Coli, 3).
Next steps
- See all 37 Meridian Bioscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYR, Meridian Bioscience, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.