510(k) K946158 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
| Applicant | Incstar Corp., Stillwater MN, US |
| Decision | Substantially Equivalent, Jun 9, 1995 |
| Received | Dec 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2007 | Diasorin Inc. DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic.
For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Terminated |
LLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.