FDA 510(k) Applications Submitted by SUSAN D ROLIH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K153661 |
12/21/2015 |
ImmunoCard STAT! HpSA |
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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