The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Sabouraud Dextrose Agar Tube.
| Device ID | K840078 |
| 510k Number | K840078 |
| Device Name: | SABOURAUD DEXTROSE AGAR TUBE |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-09 |
| Decision Date | 1984-01-30 |