The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Rubenosticon.
| Device ID | K780063 |
| 510k Number | K780063 |
| Device Name: | RUBENOSTICON |
| Classification | Antisera, Hai (including Hai Control), Rubella |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOK |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-12 |
| Decision Date | 1978-01-20 |