510(k) K981163 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
DIAMEDIX IS-CMV IGG TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Sep 21, 1998 |
| Received | Mar 31, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2015 | Diamedix Corporation Diamedix Is-CMV IgG Test Kit Terminated |
LFZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.