Medical Device Manufacturer · US , San Diego , CA

Genbio - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1996

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genbio Microbiology ✕

10 devices

1-10 of 10

Cleared Jun 11, 2001

IMMUNOWELL EA (D) IGG TEST

Microbiology · 130d

Cleared Sep 22, 1998

IMMUNODOT MONO-G TEST

Microbiology · 314d

Cleared Sep 22, 1998

IMMUNODOT MONO-M TEST

Microbiology · 314d

Cleared Aug 10, 1998

IMMUNOWELL VCA IGM TEST

Microbiology · 299d

Cleared Aug 10, 1998

IMMUNOWELL EBV VCA IGG TEST

Microbiology · 299d

Cleared Aug 10, 1998

IMMUNOWELL EBNA IGG TEST

Microbiology · 299d

Cleared May 05, 1997

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

Microbiology · 272d

Cleared May 02, 1997

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120

Microbiology · 269d

Cleared May 03, 1996

IMMUNO DOT BORRELIA DOT BLOT G TEST

Microbiology · 270d

Cleared May 03, 1996

MMUNO DOT BORRELIA DOT BLOT M TEST

Microbiology · 270d