510(k) K060266 ยท JIS Calibrator, Primary
DIMENSION IRON CALIBRATOR
| Applicant | Dade Behring, Inc., Newark, DE, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Feb 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060266
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010.
The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dime Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.