The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Rubella Igm Elisa Test System.
| Device ID | K914028 |
| 510k Number | K914028 |
| Device Name: | RUBELLA IGM ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Joseph A Rosebrock |
| Correspondent | Joseph A Rosebrock ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1992-04-22 |