510(k) K122599 ยท DDR Myoglobin, Antigen, Antiserum, Control
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 3, 2012 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Calibrator U,
For in vitro diagnostic use in calibrating the following assays using
ADVIA Centaur"' systems: Myoglobin cTnl
Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.