The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Decarboxylase Media, Ornithine.
| Device ID | K862398 |
| 510k Number | K862398 |
| Device Name: | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE |
| Classification | Culture Media, Single 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 | JSF |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-07-03 |