510(k) K052000 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
ARCHITECT CA 19-9XR ASSAY
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 25, 2005 |
| Received | Jul 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2012 | Abbott Laboratories ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests);
Product Usage:
The ARCHITECT CA 19-9XR assay is a chemiluminescent Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.