Medical Device Manufacturer · US , Cincinnati , OH

Meridian Bioscience, Inc. - FDA 510(k) Cleared Devices

38 submissions · 37 cleared · Since 2003

38

Total

37

Cleared

1

Denied

38 devices

26-38 of 38

Cleared Jul 09, 2010

ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL...

Microbiology · 108d

Cleared Sep 11, 2009

TRU FLU, MODEL 751230

Microbiology · 22d

Cleared May 28, 2009

IMMUNOCARD STAT CAMPY, MODEL 751530

Microbiology · 72d

Cleared Jan 30, 2009

PREMIER CAMPY, MODEL 618096

Microbiology · 67d

Cleared Nov 15, 2007

Microbiology · 150d

Cleared Oct 18, 2007

Microbiology · 182d

Cleared Feb 14, 2007

IMMUNOCARD STAT! EHEC, MODEL 751630

Microbiology · 168d

Cleared Mar 10, 2006

PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

Microbiology · 99d

Cleared Mar 16, 2005

IMMUNOCARD STAT! FLU A & B

Microbiology · 273d

Cleared Aug 20, 2004

IMMUNOCARD TOXINS A & B, MODEL 712050

Microbiology · 123d

Cleared Aug 13, 2004

IMMUNOCARD STAT! RSV MODEL #750630

Microbiology · 73d

Cleared Dec 05, 2003

IMMUNOCARDSTAT HPSA

Microbiology · 137d

Cleared Jan 03, 2003

IMMUNOCARD STAT! E. COLI O157 PLUS

Microbiology · 67d