FDA 510(k) Applications Submitted by Meridian Bioscience, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K192817 |
10/01/2019 |
Curian HpSA, Curian Analyzer |
Meridian Bioscience, Inc. |
| K230901 |
03/31/2023 |
Premier HpSA Flex (619096) |
Meridian Bioscience, Inc. |
| K210976 |
04/01/2021 |
Curian Campy |
Meridian Bioscience, Inc. |
| DEN180040 |
07/30/2018 |
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
Meridian Bioscience, Inc. |
| K182559 |
09/17/2018 |
PREMIER Platinum HpSA PLUS |
Meridian Bioscience, Inc. |
| K163273 |
11/21/2016 |
TRU Legionella |
MERIDIAN BIOSCIENCE, INC. |
| K110012 |
01/03/2011 |
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 |
MERIDIAN BIOSCIENCE, INC. |
| K090700 |
03/17/2009 |
IMMUNOCARD STAT CAMPY, MODEL 751530 |
MERIDIAN BIOSCIENCE, INC. |
| K100818 |
03/23/2010 |
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 |
MERIDIAN BIOSCIENCE, INC. |
| K121044 |
04/06/2012 |
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM |
MERIDIAN BIOSCIENCE, INC. |
| K122019 |
07/10/2012 |
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS |
MERIDIAN BIOSCIENCE, INC. |
| K123423 |
11/06/2012 |
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT |
MERIDIAN BIOSCIENCE, INC. |
| K133673 |
11/29/2013 |
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA |
MERIDIAN BIOSCIENCE, INC. |
| K160829 |
03/25/2016 |
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
| K151046 |
04/20/2015 |
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
| K152800 |
09/28/2015 |
illumigene Mycoplasma DNA Amplification Assay |
MERIDIAN BIOSCIENCE, INC. |
| K110620 |
03/03/2011 |
PREMIER C. DIFFICILE GDH |
MERIDIAN BIOSCIENCE, INC. |
| K112048 |
07/18/2011 |
IMMUNOCARD C. DIFFICILE GDH |
MERIDIAN BIOSCIENCE, INC. |
| K113190 |
10/31/2011 |
TRU LEGIONELLA |
MERIDIAN BIOSCIENCE, INC. |
| K041003 |
04/19/2004 |
IMMUNOCARD TOXINS A & B, MODEL 712050 |
MERIDIAN BIOSCIENCE, INC. |
| K071101 |
04/19/2007 |
TRU RSV |
MERIDIAN BIOSCIENCE, INC. |
| K041445 |
06/01/2004 |
IMMUNOCARD STAT! RSV MODEL #750630 |
MERIDIAN BIOSCIENCE, INC. |
| K041626 |
06/16/2004 |
IMMUNOCARD STAT! FLU A & B |
MERIDIAN BIOSCIENCE, INC. |
| K071657 |
06/18/2007 |
TRU FLU |
MERIDIAN BIOSCIENCE, INC. |
| K032222 |
07/21/2003 |
IMMUNOCARDSTAT HPSA |
MERIDIAN BIOSCIENCE, INC. |
| K152285 |
08/12/2015 |
illumigene Pertussis DNA Amplification Assay |
MERIDIAN BIOSCIENCE, INC. |
| K092553 |
08/20/2009 |
TRU FLU, MODEL 751230 |
MERIDIAN BIOSCIENCE, INC. |
| K062546 |
08/30/2006 |
IMMUNOCARD STAT! EHEC, MODEL 751630 |
MERIDIAN BIOSCIENCE, INC. |
| K023599 |
10/28/2002 |
IMMUNOCARD STAT! E. COLI O157 PLUS |
MERIDIAN BIOSCIENCE, INC. |
| K053335 |
12/01/2005 |
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 |
MERIDIAN BIOSCIENCE, INC. |
| K133714 |
12/05/2013 |
TRU FLU |
MERIDIAN BIOSCIENCE, INC. |
| K112125 |
07/25/2011 |
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT |
MERIDIAN BIOSCIENCE, INC. |
| K083464 |
11/24/2008 |
PREMIER CAMPY, MODEL 618096 |
MERIDIAN BIOSCIENCE, INC. |
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