Genbio is one of 8079 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genbio - FDA 510(k) Cleared Devices
Recent clearances: IMMUNODOT MONO-G TEST, IMMUNODOT MONO-M TEST, IMMUNOWELL VCA IGM TEST
10
Total
10
Cleared
0
Denied
Genbio has 10 FDA 510(k) cleared microbiology devices. Based in San Diego, US.
Historical record: 10 cleared submissions from 1996 to 2001.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genbio
10 devices
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