Atlas FDA

DIMENSION VISTA INTEGRATED SYSTEM

FDA 510(k) clearance K051087 · decided 2005-07-11

Clearance details

K-number
K051087
Device name
DIMENSION VISTA INTEGRATED SYSTEM
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2005-04-28
Decision date
2005-07-11
Days to decision
74 days
Clearance type
Traditional
Product code
JJE
Device class
1
Regulation number
862.2160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System recall (Z-1703-2017)Siemens Healthcare Diagnostics, Inc.2017-03-19
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3 recall (Z-1885-2016)Siemens Healthcare Diagnostics Inc.2016-06-01
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V. recall (Z-1886-2016)Siemens Healthcare Diagnostics Inc.2016-06-01
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Inte recall (Z-2054-2015)Siemens Healthcare Diagnostics, Inc.2015-07-09
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: recall (Z-0838-2015)Siemens Healthcare Diagnostics, Inc.2014-12-20
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product fo recall (Z-0024-2015)Siemens Healthcare Diagnostics, Inc.2014-10-06
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: recall (Z-1733-2014)Siemens Healthcare Diagnostics, Inc.2014-06-09
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 Sy recall (Z-0851-2014)Siemens Healthcare Diagnostics, Inc.2014-01-28
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to sys recall (Z-0430-2014)Siemens Healthcare Diagnostics, Inc.2013-12-02
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with soft recall (Z-2088-2013)Siemens Healthcare Diagnostics, Inc.2013-08-26
Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista recall (Z-1454-2012)Siemens Healthcare Diagnostics, Inc.2012-04-25
Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is f recall (Z-0644-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Sta recall (Z-0645-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the recall (Z-0646-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension V recall (Z-0031-2012)Siemens Healthcare Diagnostics, Inc.2011-10-07
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on th recall (Z-0139-2011)Siemens Healthcare Diagnostics, Inc.2010-10-25
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classi recall (Z-0121-2011)Siemens Healthcare Diagnostics, Inc.2010-10-21
Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with A recall (Z-2423-2010)Siemens Healthcare Diagnostics, Inc.2010-09-15
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS85 recall (Z-2117-2010)Siemens Healthcare Diagnostics, Inc.2010-08-02
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers recall (Z-1205-2010)Siemens Healthcare Diagnostics, Inc.2010-03-24
Dimension Vista V-LYTE Fluids: Standard A catalog number K820 recall (Z-1037-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 recall (Z-1038-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
Dimension Vista V-LYTE Fluids: Diluent catalog number K835 recall (Z-1039-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnost recall (Z-1017-2010)Siemens Healthcare Diagnostics, Inc.2010-03-08
Dimension Vista LOCI Reaction Vessel recall (Z-0980-2010)Siemens Healthcare Diagnostics, Inc.2010-03-05
EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista recall (Z-1991-2009)Siemens Healthcare Diagnostics, Inc.2009-09-29
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING IN recall (Z-1174-2007)Dade Behring, Inc.2007-08-22

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02