510(k) K981831 ยท GNP Antiserum, Cf, Epstein-Barr Virus
IS EBV-EA-D IGG ELISA TEST SYSTEM
| Applicant | Diamedix Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 16, 1999 |
| Received | May 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2018 | Diamedix Corporation Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640 Terminated |
GNP | None listed |
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-EBV-EA-D 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 o Terminated |
GNP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.