510(k) K000238 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
| Applicant | Mrl Diagnostics, Cypress CA, US |
| Decision | Substantially Equivalent, Apr 14, 2000 |
| Received | Jan 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2008 | Focus Diagnostics Inc HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G
Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. Terminated |
LGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.