510(k) K962559 ยท JFT Fluorometric, Cortisol
ACS CORTISOL IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 5, 1996 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use i Open, Classified |
JFT | None listed |
| Apr 9, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Cortisol Assay
Cat. Nos.
04610138 (1 0321 026)- 250 Test kit
04610049(10309078)- 50 Test kit
04611509 (1 0335503)- 250 REF Test kit
ADVIA Centaur Systems Cortisol: For in vitro Terminated |
JFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.