510(k) K083867 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 27, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2010 | Beckman Coulter Inc. Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantit Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.