The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Hektoen Enteric Agar Plate.
| Device ID | K832535 |
| 510k Number | K832535 |
| Device Name: | HEKTOEN ENTERIC AGAR PLATE |
| Classification | Culture Media, Selective And Differential |
| Applicant | OTISVILLE BIOTECH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-29 |
| Decision Date | 1983-10-04 |