510(k) K992191 ยท LSE Epstein-Barr Virus, Other
ETI-EA-G ASSAY
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jul 12, 1999 |
| Received | Jun 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2005 | Diasorin Inc. DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C Terminated |
LSE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.