The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Mycotrim Tm Vl Triphasic Culture System.
| Device ID | K855205 |
| 510k Number | K855205 |
| Device Name: | MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM |
| Classification | Culture Media, Selective And Differential |
| Applicant | HANA BIOLOGICS, INC. 626 BANCROFT WAY Berkeley, CA 94710 |
| Contact | Robert Berkowitz |
| Correspondent | Robert Berkowitz HANA BIOLOGICS, INC. 626 BANCROFT WAY Berkeley, CA 94710 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-02-05 |