Medical Device Manufacturer · US , Everett , WA

Neogenex - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1994

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Neogenex Microbiology ✕

7 devices

1-7 of 7

Cleared Feb 04, 1997

MINK LUNG CELL CULTURE

Microbiology · 48d

Cleared May 30, 1996

H292 CELL CULTURE

Microbiology · 86d

Cleared Jul 18, 1994

CHLAMYDIA TRACHOMATIS ANTIGEN TEST

Microbiology · 117d

Cleared Jul 06, 1994

INFLUENZA A ANTIGEN TEST

Microbiology · 62d

Cleared Jun 30, 1994

CMV EARLY ANTIGEN TEST

Microbiology · 56d

Cleared Jun 30, 1994

RSV ANTIGEN TEST

Microbiology · 56d

Cleared Jun 30, 1994

INFLUENZA B ANITGEN TEST

Microbiology · 56d