The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for In Fluenza B Virus.
| Device ID | K843660 |
| 510k Number | K843660 |
| Device Name: | IN FLUENZA B VIRUS |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | INSTITUTE VIRION LTD. 6605 ASCOT DR. Oakland, CA 94611 |
| Contact | Lennette Md |
| Correspondent | Lennette Md INSTITUTE VIRION LTD. 6605 ASCOT DR. Oakland, CA 94611 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1985-09-26 |