The following data is part of a premarket notification filed by Microbix Biosystems, Inc. with the FDA for Rubella Antigen And Control Antigen.
| Device ID | K894262 |
| 510k Number | K894262 |
| Device Name: | RUBELLA ANTIGEN AND CONTROL ANTIGEN |
| Classification | Antigen, Cf (including Cf Control), Rubella |
| Applicant | MICROBIX BIOSYSTEMS, INC. DARTS MILL Flemington, NJ 08822 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone MICROBIX BIOSYSTEMS, INC. DARTS MILL Flemington, NJ 08822 |
| Product Code | GON |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-21 |
| Decision Date | 1989-10-16 |