The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Mycotrium-rs.
| Device ID | K822737 |
| 510k Number | K822737 |
| Device Name: | MYCOTRIUM-RS |
| Classification | Culture Media, Selective And Differential |
| Applicant | HANA BIOLOGICS, 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 | 1982-09-09 |
| Decision Date | 1982-12-03 |