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Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

DateFirm and productCodeLinked 510(k)
Nov 5, 2013Roche Diagnostics Operations, Inc.
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling access
Terminated
JJEK951595
Oct 18, 2013OPTI Medical Systems, Inc
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sod
Terminated
JJEK052027
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
JJEK051087
Aug 2, 2013Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quali
Terminated
JJEK112412
Jul 31, 2013Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Terminated
JJEK112412
Jul 2, 2013Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical in
Terminated
JJEK083173
Jul 2, 2013Ortho-Clinical Diagnostics
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interes
Terminated
JJEK081543
Jul 2, 2013Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest
Terminated
JJEK031924
Jul 2, 2013Ortho-Clinical Diagnostics
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitat
Terminated
JJEK031924
Jun 6, 2013Ortho-Clinical Diagnostics
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following V
Terminated
JJEK031924
K063144 +1
May 29, 2013Beckman Coulter Inc.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Terminated
JJEK003721
K011720
May 23, 2013Roche Diagnostics Operations, Inc.
Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantit
Terminated
JJEK100853
Apr 24, 2013Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagent
Terminated
JJEK112412
Apr 13, 2013Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Terminated
JJEK081543
Apr 13, 2013Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
Terminated
JJEK031924
Apr 13, 2013Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
Terminated
JJEK031924
K063144
Apr 1, 2013Siemens 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
JJEK073604
Apr 1, 2013Siemens 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
JJEK073604
Apr 1, 2013Siemens 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
JJEK073604
Apr 1, 2013Beckman Coulter Inc.
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative
Terminated
JJEK060256
Apr 1, 2013Beckman Coulter Inc.
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination
Terminated
JJEK023049
Apr 1, 2013Beckman Coulter Inc.
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analy
Terminated
JJENone listed
Apr 1, 2013Beckman Coulter Inc.
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of va
Terminated
JJEK922823
Mar 6, 2013Beckman Coulter Inc.
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Terminated
JJEK112412
Jan 30, 2013Ortho-Clinical Diagnostics
Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially in
Terminated
JJENone listed
Jan 18, 2013Roche Diagnostics Operations, Inc.
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Terminated
JJEK951595
Jan 3, 2013Horiba Instruments, Inc dba Horiba Medical
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro d
Terminated
JJEK103788
Dec 22, 2012Beckman Coulter Inc.
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186
Terminated
JJEK023049
K060256 +1
Dec 21, 2012Radiometer America Inc
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Terminated
JJEK771444
Dec 4, 2012Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Terminated
JJENone listed
Nov 19, 2012Beckman Coulter Inc.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
Terminated
JJEK023764
Nov 19, 2012Beckman Coulter Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
Terminated
JJEK023764
Oct 24, 2012Beckman Coulter Inc.
UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro d
Terminated
JJEK042291
K060256 +1
Oct 12, 2012Beckman Coulter Inc.
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synch
Terminated
JJEK042291
K060256 +1
Aug 23, 2012Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro
Terminated
JJEK023764
K042291
Aug 23, 2012Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-qu
Terminated
JJEK023764
K042291
Aug 23, 2012Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an
Terminated
JJEK023764
K042291
Aug 9, 2012Siemens 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
JJEK112999
Jul 23, 2012Ortho-Clinical Diagnostics
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Terminated
JJEK081543
Jul 23, 2012Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Terminated
JJEK031924
Jul 23, 2012Ortho-Clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Terminated
JJEK031924
Jun 1, 2012Ortho-Clinical Diagnostics
VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical in
Terminated
JJEK081543
Apr 26, 2012Ortho-Clinical Diagnostics
VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative me
Terminated
JJEK063144
Apr 26, 2012Ortho-Clinical Diagnostics
VITROS® 5,1 FS System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of
Terminated
JJEK063144
Apr 26, 2012Ortho-Clinical Diagnostics
VITROS® 5600 Chemistry System, Product Code: 6802413 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes
Terminated
JJEK081543
Apr 26, 2012Ortho-Clinical Diagnostics
VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VI
Terminated
JJEK031924
Apr 26, 2012Ortho-Clinical Diagnostics
VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical inter
Terminated
JJEK083173
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
JJEK051087
Apr 10, 2012Siemens Healthcare Diagnostics, Inc.
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as
Terminated
JJENone listed
Apr 6, 2012Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number: A54379, UniCel DxC 600i AAF. The Access Im
Terminated
JJEK060256

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