510(k) K081683 ยท JIT Calibrator, Secondary
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jul 7, 2008 |
| Received | Jun 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension LOCI TNI Troponin I Calibrator RC 621.
The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Di Terminated |
JIT | None listed |
| Jan 11, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic Terminated |
JIT | None listed |
| Oct 12, 2011 | Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)
The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.