510(k) K142723 ยท JFT Fluorometric, Cortisol
ADVIA Centaur Cortisol (COR) Assy
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 31, 2015 |
| Received | Sep 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in Open, Classified |
JFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.