510(k) K052082 ยท JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 19, 2005 |
| Received | Aug 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2017 | Beckman Coulter Inc. Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C Terminated |
JMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.