Meridian Bioscience, Inc.
FDA 510(k) & PMA Approved Devices — 32 products
Total Devices32
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243922 | Revogene | OOI | 2025-03-20 | View |
| 510(k) | K230901 | Premier HpSA Flex (619096) | LYR | 2023-07-03 | View |
| 510(k) | K222829 | Curian® Shiga Toxin | GMZ | 2023-04-17 | View |
| 510(k) | K222779 | Revogene | OOI | 2023-01-26 | View |
| 510(k) | K220480 | Revogene | OOI | 2022-07-11 | View |
| 510(k) | K210976 | Curian Campy | LQP | 2021-12-23 | View |
| 510(k) | K192817 | Curian HpSA, Curian Analyzer | LYR | 2020-03-13 | View |
| 510(k) | K182559 | PREMIER Platinum HpSA PLUS | LYR | 2018-11-05 | View |
| 510(k) | K163273 | TRU Legionella | MJH | 2017-02-21 | View |
| 510(k) | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | OZX | 2016-06-13 | View |
| 510(k) | K153661 | ImmunoCard STAT! HpSA | LYR | 2016-03-14 | View |
| 510(k) | K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | OZX | 2013-06-05 | View |
| 510(k) | K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | OYZ | 2012-09-13 | View |
| 510(k) | K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | NJR | 2012-05-01 | View |
| 510(k) | K113190 | TRU LEGIONELLA | MJH | 2012-02-24 | View |
| 510(k) | K112048 | IMMUNOCARD C. DIFFICILE GDH | MCB | 2011-12-16 | View |
| 510(k) | K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | NJR | 2011-12-05 | View |
| 510(k) | K110620 | PREMIER C. DIFFICILE GDH | MCB | 2011-05-03 | View |
| 510(k) | K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | OMN | 2011-02-24 | View |
| 510(k) | K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | OMN | 2010-07-09 | View |
No matching devices.