510(k) K002262 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Nov 28, 2000 |
| Received | Jul 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2012 | Diamedix Corporation Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient Terminated |
LGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.