Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

38 results for "Meridian Bioscience, Inc."
25–38 of 38
Search insights Median review: 94d Cleared: 97% Top manufacturer: Meridian Bioscience, Inc. Lead specialty: Microbiology
Cleared Feb 24, 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012 · OMN
Meridian Bioscience, Inc.
Microbiology · 52d
Cleared Jul 09, 2010
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL...
K100818 · OMN
Meridian Bioscience, Inc.
Microbiology · 108d
Cleared Sep 11, 2009
TRU FLU, MODEL 751230
K092553 · PSZ
Meridian Bioscience, Inc.
Microbiology · 22d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · LQP
Meridian Bioscience, Inc.
Microbiology · 72d
Cleared Jan 30, 2009
PREMIER CAMPY, MODEL 618096
K083464 · LQP
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Nov 15, 2007
TRU FLU
K071657 · PSZ
Meridian Bioscience, Inc.
Microbiology · 150d
Cleared Oct 18, 2007
TRU RSV
K071101 · GOG
Meridian Bioscience, Inc.
Microbiology · 182d
Cleared Feb 14, 2007
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546 · GMZ
Meridian Bioscience, Inc.
Microbiology · 168d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · LYR
Meridian Bioscience, Inc.
Microbiology · 99d
Cleared Mar 16, 2005
IMMUNOCARD STAT! FLU A & B
K041626 · PSZ
Meridian Bioscience, Inc.
Microbiology · 273d
Cleared Aug 20, 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · LLH
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Aug 13, 2004
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · GQG
Meridian Bioscience, Inc.
Microbiology · 73d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222 · LYR
Meridian Bioscience, Inc.
Microbiology · 137d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · GMZ
Meridian Bioscience, Inc.
Microbiology · 67d