Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meridian Bioscience, Inc. — Predicate Candidate Screening
38 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
210 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243922 | Revogene | Meridian Bioscience, Inc. | 2025-03-20 | 90 | 0 |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023-07-03 | 94 | 0 |
| K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023-04-17 | 210 | 0 |
| K222779 | Revogene | Meridian Bioscience, Inc. | 2023-01-26 | 134 | 0 |
| K220480 | Revogene | Meridian Bioscience, Inc. | 2022-07-11 | 143 | 0 |
| K210976 | Curian Campy | Meridian Bioscience, Inc. | 2021-12-23 | 266 | 0 |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | 2020-03-13 | 164 | 0 |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Co | Meridian Bioscience, Inc. | 2018-11-30 | 123 | 0 |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018-11-05 | 49 | 0 |
| K163273 | TRU Legionella | Meridian Bioscience, Inc. | 2017-02-21 | 92 | 0 |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumi | Meridian Bioscience, Inc. | 2016-06-13 | 80 | 0 |
| K153661 | ImmunoCard STAT! HpSA | Meridian Bioscience, Inc. | 2016-03-14 | 84 | 0 |
| K152285 | illumigene Pertussis DNA Amplification Assay | Meridian Bioscience, Inc. | 2015-11-10 | 90 | 0 |
| K152800 | illumigene Mycoplasma DNA Amplification Assay | Meridian Bioscience, Inc. | 2015-10-23 | 25 | 0 |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1 | Meridian Bioscience, Inc. | 2015-07-17 | 88 | 0 |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERT | Meridian Bioscience, Inc. | 2014-03-25 | 116 | 0 |
| K133714 | TRU FLU | Meridian Bioscience, Inc. | 2014-01-03 | 29 | 0 |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGE | Meridian Bioscience, Inc. | 2013-06-05 | 211 | 0 |
| K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | Meridian Bioscience, Inc. | 2012-09-13 | 65 | 0 |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | Meridian Bioscience, Inc. | 2012-05-01 | 25 | 1 |
| K113190 | TRU LEGIONELLA | Meridian Bioscience, Inc. | 2012-02-24 | 116 | 0 |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-12-16 | 151 | 0 |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | Meridian Bioscience, Inc. | 2011-12-05 | 133 | 0 |
| K110620 | PREMIER C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-05-03 | 61 | 0 |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | Meridian Bioscience, Inc. | 2011-02-24 | 52 | 2 |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFF | Meridian Bioscience, Inc. | 2010-07-09 | 108 | 0 |
| K092553 | TRU FLU, MODEL 751230 | Meridian Bioscience, Inc. | 2009-09-11 | 22 | 0 |
| K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | Meridian Bioscience, Inc. | 2009-05-28 | 72 | 0 |
| K083464 | PREMIER CAMPY, MODEL 618096 | Meridian Bioscience, Inc. | 2009-01-30 | 67 | 0 |
| K071657 | TRU FLU | Meridian Bioscience, Inc. | 2007-11-15 | 150 | 0 |
| K071101 | TRU RSV | Meridian Bioscience, Inc. | 2007-10-18 | 182 | 0 |
| K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | Meridian Bioscience, Inc. | 2007-02-14 | 168 | 0 |
| K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | Meridian Bioscience, Inc. | 2006-03-10 | 99 | 0 |
| K041626 | IMMUNOCARD STAT! FLU A & B | Meridian Bioscience, Inc. | 2005-03-16 | 273 | 0 |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | Meridian Bioscience, Inc. | 2004-08-20 | 123 | 1 |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | Meridian Bioscience, Inc. | 2004-08-13 | 73 | 0 |
| K032222 | IMMUNOCARDSTAT HPSA | Meridian Bioscience, Inc. | 2003-12-05 | 137 | 0 |
| K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | Meridian Bioscience, Inc. | 2003-01-03 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda