510(k) K073604 ยท CEC Radioimmunoassay, Free Thyroxine
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 13, 2008 |
| Received | Dec 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. Terminated |
JJE | None listed |
| Jul 30, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. Terminated |
JJE | None listed |
| Apr 1, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890).
Intended to measure a variety of analytes in human body fluids. Terminated |
JJE | None listed |
| Apr 1, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377).
Intended to measure a variety of analytes in human body fluids. Terminated |
JJE | None listed |
| Apr 1, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929).
Intended to measure a variety of analytes in human body fluids. Terminated |
JJE | None listed |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
CEC | None listed |
| Jan 13, 2009 | Dade Behring, Inc. Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.
The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.