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

92 results for "Meridian Diagnostics, Inc."
1–24 of 92
Search insights Median review: 32d Cleared: 100% Top manufacturer: Meridian Diagnostics, Inc. Lead specialty: Microbiology
Cleared Dec 10, 1999
PREMIER TOXINS A&B, MODEL 616096
K993914 · LLH
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · GMZ
Meridian Diagnostics, Inc.
Microbiology · 194d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · LGC
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · MXJ
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Dec 17, 1998
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · LYR
Meridian Diagnostics, Inc.
Microbiology · 93d
Cleared Dec 03, 1998
PREMIER CRYPTOSPORIDIUM
K982764 · MHJ
Meridian Diagnostics, Inc.
Microbiology · 119d
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711 · MHI
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076 · LYR
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared Apr 02, 1998
PARA-PAK SPINCON
K980077 · LKS
Meridian Diagnostics, Inc.
Microbiology · 84d
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 111d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508 · LYR
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared May 23, 1996
PREMIER HSV PLUS
K953839 · LGC
Meridian Diagnostics, Inc.
Microbiology · 281d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859 · LLH
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Nov 14, 1995
PREMIER EHEC
K953362 · GNA
Meridian Diagnostics, Inc.
Microbiology · 120d
Cleared Apr 14, 1995
PREMIER EHEC
K950167 · GNA
Meridian Diagnostics, Inc.
Microbiology · 87d
Cleared Mar 03, 1995
PREMIER(TM) H. PYLORY
K945558 · LYR
Meridian Diagnostics, Inc.
Microbiology · 109d
Cleared Dec 08, 1994
IMMUNOCARD H. PYLORI
K941560 · LYR
Meridian Diagnostics, Inc.
Microbiology · 251d
Cleared Oct 27, 1994
MICROSPORIDIUM CONTROL SET
K943228 · LJG
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 20, 1994
IMMUNOCARD MYCOPLASMA
K934550 · LJZ
Meridian Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 03, 1994
IMMUNOCARD ROTAVIRUS
K933587 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 192d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778 · KTN
Meridian Diagnostics, Inc.
Immunology · 314d
Cleared Jun 15, 1993
PARA-PAK PLUS
K931770 · LIO
Meridian Diagnostics, Inc.
Microbiology · 67d
Cleared Jan 27, 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442 · LLH
Meridian Diagnostics, Inc.
Microbiology · 42d
Cleared Jan 26, 1993
IMMUNOCARD(TM) C. DIFFICILE
K924979 · LLH
Meridian Diagnostics, Inc.
Microbiology · 117d