The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Kligler Iron Agar.
| Device ID | K843768 |
| 510k Number | K843768 |
| Device Name: | BIOTIS KLIGLER IRON AGAR |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-10-10 |