510(k) K223405 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Access Testosterone
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 13, 2023 |
| Received | Nov 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2025 | Beckman Coulter, Inc. Access Testosterone assay, Catalog Number 33560 Open, Classified |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.