510(k) K994115 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 28, 2000 |
| Received | Dec 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge.
An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. Terminated |
JMO | None listed |
| Sep 8, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum Terminated |
JMO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.