The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Rubella Virus Immunological Test System.
| Device ID | K911444 |
| 510k Number | K911444 |
| Device Name: | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Contact | Karen Vukobratovich |
| Correspondent | Karen Vukobratovich WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-08-30 |