Otisville Biopharm, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Otisville Biopharm, Inc. Microbiology ✕
8 devices
Cleared
Feb 05, 1988
BIOTIS (TM) HAEMOPHILUS DUCREYI
Microbiology
115d
Cleared
Jan 28, 1988
BIOTIS (TM) SABHI (DOUBLE POUR)
Microbiology
107d
Cleared
Dec 04, 1987
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
Microbiology
52d
Cleared
Dec 04, 1987
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
Microbiology
52d
Cleared
Dec 04, 1987
BIOTIS (TM) BCYE
Microbiology
50d
Cleared
Dec 04, 1987
BIOTIS (TM) BCYE SELECTIVE
Microbiology
52d
Cleared
Oct 28, 1987
BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)
Microbiology
15d
Cleared
Oct 28, 1987
BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI
Microbiology
15d