510(k) K242190 ยท CGR Radioimmunoassay, Cortisol
Access Cortisol; DxC 500i Clinical Analyzer
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Mar 5, 2025 |
| Received | Jul 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Beckman Coulter Inc. DxC 500i Clinical Analyzer Modules:
1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522
2. DxC 500 AU Module, DxC 500i, Part No. C63521
3. Access 2 Module, DxC 500i, Part No. C13252 Open, Classified |
JJE | None listed |
| Aug 17, 2026 | Beckman Coulter Inc. Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:
1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522;
2) DxC 500 AU Module, DxC 500i, Part Number C63521; Open, Classified |
JJE | None listed |
| Oct 21, 2025 | Beckman Coulter, Inc. DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252) Open, Classified |
CGR | None listed |
| Oct 2, 2025 | Beckman Coulter Inc. DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer Open, Classified |
CGR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.