510(k) K053559 ยท LCO Platelet Factor 4 Radioimmunoassay
PF4 ENHANCED SOLID PHASE ELISA
| Applicant | Genetic Testing Institute, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 20, 2006 |
| Received | Dec 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2015 | Genetic Testing Institute,inc PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and
2. ImmucorGamma LIFECODES PF4 Enhanced (catalo Terminated |
LCO | None listed |
| Mar 28, 2013 | Genetic Testing Institute,inc Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45
GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Terminated |
LCO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.