The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Chang Medium.
| Device ID | K812820 |
| 510k Number | K812820 |
| Device Name: | CHANG MEDIUM |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | HANA BIOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-07 |
| Decision Date | 1981-11-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHANG MEDIUM 73342083 1244971 Live/Registered |
Hana Media, Inc. 1981-12-17 |