510(k) K111952 ยท JIT Calibrator, Secondary
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 19, 2011 |
| Received | Jul 11, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2012 | Beckman Coulter Inc. Access Folate WHO Calibrators, Part Number: A98033.
The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.