The following data is part of a premarket notification filed by Otisville Biopharm, Inc. with the FDA for Biotis (tm) Haemophilus Ducreyi.
| Device ID | K874176 |
| 510k Number | K874176 |
| Device Name: | BIOTIS (TM) HAEMOPHILUS DUCREYI |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | OTISVILLE BIOPHARM, INC. P.O. BOX 567 SANATORIUM RD. Otisville, NY 10963 |
| Contact | Pat Mulholland |
| Correspondent | Pat Mulholland OTISVILLE BIOPHARM, INC. P.O. BOX 567 SANATORIUM RD. Otisville, NY 10963 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-02-05 |