510(k) K010313 ยท MMI Immunoassay Method, Troponin Subunit
DIMENSION CTNI FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 20, 2001 |
| Received | Feb 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521.
Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the Terminated |
MMI | None listed |
| Aug 12, 2009 | Siemens Healthcare Diagnostics, Inc. Dimension Cardiac Troponin I Flex reagent cartridge (CTNI).
The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test inten Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.