The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Hsv-1 Type Specific Igg Assay, Control Hsv-1 Igg.
| Device ID | K081685 |
| 510k Number | K081685 |
| Device Name: | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-11-18 |
| Summary: | summary |