510(k) K981812 ยท LSE Epstein-Barr Virus, Other
EBV-VCA IGG ELISA TEST SYSTEM
| Applicant | Diamedix Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Mar 4, 1999 |
| Received | May 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-EBV-VCA IgG Test Kit
Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Terminated |
LSE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.