510(k) K050202 ยท CGR Radioimmunoassay, Cortisol
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Jan 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2018 | Beckman Coulter Inc. The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immuno Terminated |
CGR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.