The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-controls.
| Device ID | K073390 |
| 510k Number | K073390 |
| Device Name: | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Mari Meyer |
| Correspondent | Mari Meyer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-11-21 |
| Summary: | summary |