510(k) K112999 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DIMENSION CLINICAL CHEMISTRY SYSTEM
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Oct 7, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112999
| 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 |
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
CIT | None listed |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension RxL Max w/o HM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the avail Terminated |
JJE | None listed |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension RxL Max HM STM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the avai 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 |
| 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 |
| Aug 9, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Reagent Management System (RMS) - Power Cord.
The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, in Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.