The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Rubella Virus Antigens & Controls.
| Device ID | K802937 |
| 510k Number | K802937 |
| Device Name: | RUBELLA VIRUS ANTIGENS & CONTROLS |
| Classification | Antigen, Cf (including Cf Control), Rubella |
| Applicant | ORION DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GON |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1980-12-31 |