510(k) K223038 ยท CGR Radioimmunoassay, Cortisol
Access Cortisol
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 8, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2024 | Beckman Coulter, Inc. The Access Cortisol assay is a paramagnetic particle, chemiluminescent
immunoassay for the quantitative determination of cortisol levels in human
serum, plasma (heparin, EDTA) and urine using the Acce Open, Classified |
CGR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.