510(k) K954733 ยท CGR Radioimmunoassay, Cortisol
ACCESS CORTISOL ASSAY (MODIFICATION)
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 5, 1995 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2010 | Beckman Coulter Inc. Access Immunoassay Systems CORTISOL, Part Number: 33600 Terminated |
CGR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.