The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Schaedler Agar & Broth.
| Device ID | K843764 |
| 510k Number | K843764 |
| Device Name: | BIOTIS SCHAEDLER AGAR & BROTH |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-10-10 |