The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Tsi.
| Device ID | K860413 |
| 510k Number | K860413 |
| Device Name: | BIOTIS TSI |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville , NY 10963 - |
| Contact | Ernest M Green |
| Correspondent | Ernest M Green OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville , NY 10963 - |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-02-24 |