The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Measles Virus Rubeola.
Device ID | K843662 |
510k Number | K843662 |
Device Name: | MEASLES VIRUS RUBEOLA |
Classification | Antigen, Cf, (including Cf Control), Rubeola |
Applicant | INSTITUTE VIRION LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GRJ |
CFR Regulation Number | 866.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-17 |
Decision Date | 1985-09-26 |