510(k) K060818 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Jan 23, 2007 |
| Received | Mar 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2017 | Abbott Laboratories ARCHITECT SHBG Reagent
The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and p Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.