Medical Device Manufacturer · US , Everett , WA

Neogenex

20 submissions · 20 cleared · Since 1994
20
Total
20
Cleared
0
Denied

Neogenex — FDA 510(k) Submissions

Neogenex has submitted 20 FDA 510(k) premarket notifications since 1994, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cells, Animal And Human, Cultured, Antisera, Cf, Influenza Virus A, B, C, Respiratory Syncytial Virus, Antigen, Antibody, Ifa, Antiserum, Fluorescent, Chlamydia Trachomatis, Antiserum, Cf, Cytomegalovirus . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
MINK LUNG CELL CULTURE
K965047 · KIR Cells, Animal And Human,... · Microbiology
Feb 1997 48d
H292 CELL CULTURE
K960909 · KIR Cells, Animal And Human,... · Microbiology
May 1996 86d
PRIMARY MONKEY KIDNEY CELL CULTURE
K943884 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
PRIMARY RABBIT KIDNEY CELL CULTURE
K943885 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
BGM CELL CULTURE
K943886 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
HUMAN NEWBORN FORESKIN CELL CULTURE
K943887 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
MDCK CELL CULTURE
K943888 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
VERO CELL CULTURE
K943889 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
WI38 CELL CULTURE
K943890 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
RD CULTURE CELL
K943891 · KIR Cells, Animal And Human,... · Pathology
Nov 1994 111d
CHLAMYDIA TRACHOMATIS ANTIGEN TEST
K941714 · LJP Antiserum, Fluorescent,... · Microbiology
Jul 1994 117d
INFLUENZA A ANTIGEN TEST
K942172 · GNW Antisera, Cf, Influenza... · Microbiology
Jul 1994 62d
CMV EARLY ANTIGEN TEST
K942171 · GQI Antiserum, Cf,... · Microbiology
Jun 1994 56d
RSV ANTIGEN TEST
K942173 · LKT Respiratory Syncytial... · Microbiology
Jun 1994 56d
INFLUENZA B ANITGEN TEST
K942174 · GNW Antisera, Cf, Influenza... · Microbiology
Jun 1994 56d
HEP-2 CULTURE CELL
K933927 · KIR Cells, Animal And Human,... · Pathology
Mar 1994 233d
A549 CULTURE CELL
K933923 · KIR Cells, Animal And Human,... · Pathology
Mar 1994 231d
MCCOY CULTURE CELL
K933924 · KIR Cells, Animal And Human,... · Pathology
Mar 1994 231d
MRC-5 CULTURE CELL
K933925 · KIR Cells, Animal And Human,... · Pathology
Mar 1994 231d
LLCMK2 CULTURE CELLS
K933926 · KIR Cells, Animal And Human,... · Pathology
Mar 1994 231d
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