Neogenex

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K965047MINK LUNG CELL CULTUREFebruary 4, 1997
K960909H292 CELL CULTUREMay 30, 1996
K943885PRIMARY RABBIT KIDNEY CELL CULTURENovember 28, 1994
K943884PRIMARY MONKEY KIDNEY CELL CULTURENovember 28, 1994
K943891RD CULTURE CELLNovember 28, 1994
K943889VERO CELL CULTURENovember 28, 1994
K943886BGM CELL CULTURENovember 28, 1994
K943888MDCK CELL CULTURENovember 28, 1994
K943890WI38 CELL CULTURENovember 28, 1994
K943887HUMAN NEWBORN FORESKIN CELL CULTURENovember 28, 1994
K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTJuly 18, 1994
K942172INFLUENZA A ANTIGEN TESTJuly 6, 1994
K942171CMV EARLY ANTIGEN TESTJune 30, 1994
K942174INFLUENZA B ANITGEN TESTJune 30, 1994
K942173RSV ANTIGEN TESTJune 30, 1994
K933927HEP-2 CULTURE CELLMarch 31, 1994
K933923A549 CULTURE CELLMarch 29, 1994
K933925MRC-5 CULTURE CELLMarch 29, 1994
K933926LLCMK2 CULTURE CELLSMarch 29, 1994
K933924MCCOY CULTURE CELLMarch 29, 1994