510(k) K973743 ยท CHP Radioimmunoassay, Estradiol
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 31, 1997 |
| Received | Oct 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2010 | Beckman Coulter Inc. Access Immunoassay Systems Estradiol, Part Number: 33540
Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradi Terminated |
CHP | None listed |
| May 29, 2003 | Beckman Coulter Inc ACCESS Estradiol Reagent Test System Terminated |
CHP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.