510(k) K081687 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Nov 10, 2008 |
| Received | Jun 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2024 | Diasorin Inc. DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 Open, Classified |
MYF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.