Otisville Biopharm, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K874176BIOTIS (TM) HAEMOPHILUS DUCREYIFebruary 5, 1988
K874179BIOTIS (TM) SABHI (DOUBLE POUR)January 28, 1988
K874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCPDecember 4, 1987
K874178BIOTIS (TM) BCYE SELECTIVEDecember 4, 1987
K874177BIOTIS (TM) BCYEDecember 4, 1987
K874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACDecember 4, 1987
K874173BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXIOctober 28, 1987
K874172BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)October 28, 1987