The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rubella Elisa Reagents Rubella Igg Anti.
| Device ID | K802102 |
| 510k Number | K802102 |
| Device Name: | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI |
| Classification | Antigen, Ha (including Ha Control), Rubella |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOL |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-03 |
| Decision Date | 1980-12-18 |