The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Rubella Rq Bio-enzabead Kit.
| Device ID | K821804 |
| 510k Number | K821804 |
| Device Name: | RUBELLA RQ BIO-ENZABEAD KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-17 |
| Decision Date | 1982-09-14 |