Medical Device Manufacturer · US , Walker , MI

Meridian Diagnostics, Inc.

92 submissions · 92 cleared · Since 1980
92
Total
92
Cleared
0
Denied

Meridian Diagnostics, Inc. — FDA 510(k) Submissions

Meridian Diagnostics, Inc. has submitted 92 FDA 510(k) premarket notifications since 1980, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagents, Clostridium Difficile Toxin, Helicobacter Pylori, Antigen, Cf And / Or Id, Coccidioides Immitis, Antigens, Histoplasma Capsulatum, All, Antiserum, Positive Control, Histoplasma Capsulatum . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
PREMIER TOXINS A&B, MODEL 616096
K993914 · LLH Reagents, Clostridium... · Microbiology
Dec 1999 23d
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · GMZ Antigens, All Types,... · Microbiology
Aug 1999 194d
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · MXJ Enzyme Linked... · Microbiology
Jun 1999 203d
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · LGC Enzyme Linked... · Microbiology
Jun 1999 203d
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · LYR Helicobacter Pylori · Microbiology
Dec 1998 93d
PREMIER CRYPTOSPORIDIUM
K982764 · MHJ Cryptosporidium Spp. · Microbiology
Dec 1998 119d
PREMIER GIARDIA
K982711 · MHI Giardia Spp. · Microbiology
Nov 1998 113d
PREMIER PLATINUM HPSA
K980076 · LYR Helicobacter Pylori · Microbiology
May 1998 124d
PARA-PAK SPINCON
K980077 · LKS Device, Parasite... · Microbiology
Apr 1998 84d
IMMUNOCARD STAT! ROTAVIRUS
K971585 · LIQ Enzyme Linked... · Microbiology
Aug 1997 111d
IMMUNOCARD H. PYLORI
K961508 · LYR Helicobacter Pylori · Microbiology
Jan 1997 277d
PREMIER HSV PLUS
K953839 · LGC Enzyme Linked... · Microbiology
May 1996 281d
IMMUNOCARD TOXIN A
K955859 · LLH Reagents, Clostridium... · Microbiology
Apr 1996 113d
PREMIER EHEC
K953362 · GNA Antisera, All Types,... · Microbiology
Nov 1995 120d
PREMIER EHEC
K950167 · GNA Antisera, All Types,... · Microbiology
Apr 1995 87d
PREMIER(TM) H. PYLORY
K945558 · LYR Helicobacter Pylori · Microbiology
Mar 1995 109d
IMMUNOCARD H. PYLORI
K941560 · LYR Helicobacter Pylori · Microbiology
Dec 1994 251d
MICROSPORIDIUM CONTROL SET
K943228 · LJG Quality Control Slides · Microbiology
Oct 1994 113d
IMMUNOCARD MYCOPLASMA
K934550 · LJZ Enzyme Linked... · Microbiology
Sep 1994 363d
IMMUNOCARD ROTAVIRUS
K933587 · LIQ Enzyme Linked... · Microbiology
Feb 1994 192d
IMMUNOCARD MONO
K930778 · KTN System, Test, Infectious... · Immunology
Dec 1993 314d
PARA-PAK PLUS
K931770 · LIO Device, Specimen Collection · Microbiology
Jun 1993 67d
PREMIER C. DIFFICILE, MODIFICATION
K926442 · LLH Reagents, Clostridium... · Microbiology
Jan 1993 42d
IMMUNOCARD(TM) C. DIFFICILE
K924979 · LLH Reagents, Clostridium... · Microbiology
Jan 1993 117d
MERITEC C. DIFFICILE CONTROLS
K924062 · MCB Antigen, C. Difficile · Microbiology
Oct 1992 68d

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