The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Rubazyme - M.
| Device ID | K810835 |
| 510k Number | K810835 |
| Device Name: | RUBAZYME - M |
| Classification | Antisera, Hai (including Hai Control), Rubella |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GOK |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-25 |
| Decision Date | 1981-05-05 |