ClearanceBrief
510(k) K051087 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

DIMENSION VISTA INTEGRATED SYSTEM

ApplicantDade Behring, Inc., Newark DE, US
DecisionSubstantially Equivalent, Jul 11, 2005
ReceivedApr 28, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K051087

DateFirm and productCodeLinked 510(k)
Oct 15, 2021Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal
Terminated
JJENone listed
Oct 15, 2021Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal
Terminated
JJENone listed
Dec 12, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Terminated
JJENone listed
Oct 16, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to deter
Terminated
JJENone listed
Mar 19, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnos
Terminated
JJENone listed
Jun 1, 2016Siemens Healthcare Diagnostics Inc.
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in
Terminated
JJENone listed
Jun 1, 2016Siemens Healthcare Diagnostics Inc.
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an i
Terminated
JJENone listed
Feb 16, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism
Terminated
CDQNone listed
Jul 9, 2015Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Terminated
JJENone listed
Dec 20, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing,
Terminated
JJENone listed
Oct 6, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Terminated
JITNone listed
Jun 9, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems.
Terminated
JJENone listed
Jan 28, 2014Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or
Terminated
JJENone listed
Dec 2, 2013Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in
Terminated
JJENone listed
Aug 26, 2013Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures
Terminated
JJENone listed
Apr 25, 2012Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipett
Terminated
JJENone listed
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system
Terminated
JJENone listed
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system
Terminated
JJENone listed
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) s
Terminated
JJENone listed
Oct 7, 2011Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplic
Terminated
JJENone listed
Oct 25, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Terminated
CEMNone listed
Oct 21, 2010Siemens Healthcare Diagnostics, Inc.
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is incl
Terminated
JJENone listed
Sep 15, 2010Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista
Terminated
JJENone listed
Aug 2, 2010Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.
Terminated
JJENone listed
Mar 24, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for
Terminated
CDTNone listed
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Standard A catalog number K820
Terminated
JJENone listed
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825
Terminated
JJENone listed
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Diluent catalog number K835
Terminated
JJENone listed
Mar 8, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Terminated
JJENone listed
Mar 5, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista LOCI Reaction Vessel
Terminated
JJENone listed
Sep 29, 2009Siemens Healthcare Diagnostics, Inc.
EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as
Terminated
JJENone listed
Aug 22, 2007Dade Behring, Inc.
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
Terminated
JJENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.