510(k) K130276 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DIMENSION EXL WITH LM SYSTEM
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 22, 2013 |
| Received | Feb 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Thermal Chamber Motor Cable located in the following models:
Model/UDI Number:
Dimension EXL 200 00630414593579;
Dimension EXL with LM 00630414593500;
Dimension EXL with LM with STM 00630414 Terminated |
JJE | None listed |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension EXL with LM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the availab Terminated |
JJE | None listed |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension EXL with LM STM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the ava Terminated |
JJE | None listed |
| 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 |
| Aug 26, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 1048689 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.