The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Chang Medium (additional Indications).
| Device ID | K883682 |
| 510k Number | K883682 |
| Device Name: | CHANG MEDIUM (ADDITIONAL INDICATIONS) |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | HANA BIOLOGICS, INC. 850 MARINA VILLAGE PKWY. Alameda, CA 94501 -1034 |
| Contact | Jean F Huxsoll |
| Correspondent | Jean F Huxsoll HANA BIOLOGICS, INC. 850 MARINA VILLAGE PKWY. Alameda, CA 94501 -1034 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-09-16 |