The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Rubella Virus.
| Device ID | K792635 |
| 510k Number | K792635 |
| Device Name: | ANTIBODY TO RUBELLA VIRUS |
| Classification | Antisera, Hai (including Hai Control), Rubella |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, 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 | 1979-12-19 |
| Decision Date | 1980-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229027011 | K792635 | 000 |
| G5229027001 | K792635 | 000 |