510(k) K060774 ยท CGN Acid, Folic, Radioimmunoassay
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Mar 22, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060774
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2012 | Beckman Coulter Inc. Access Folate Calibrators, Part Number: A14207.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.