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)
Top companies in JJE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2013 | Roche 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 |
JJE | K951595 |
| Oct 18, 2013 | OPTI 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 |
JJE | K052027 |
| Aug 26, 2013 | Siemens 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 |
JJE | K051087 |
| Aug 2, 2013 | Beckman 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 |
JJE | K112412 |
| Jul 31, 2013 | Beckman 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 |
JJE | K112412 |
| Jul 2, 2013 | Ortho-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 |
JJE | K083173 |
| Jul 2, 2013 | Ortho-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 |
JJE | K081543 |
| Jul 2, 2013 | Ortho-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 |
JJE | K031924 |
| Jul 2, 2013 | Ortho-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 |
JJE | K031924 |
| Jun 6, 2013 | Ortho-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 |
JJE | K031924 K063144 +1 |
| May 29, 2013 | Beckman Coulter Inc. AU2700 Clinical Chemistry Analyzer
AU5400 Clinical Chemistry Analyzer
Perform automated analysis of serum, urine, and other body fluids, including whole blood. Terminated |
JJE | K003721 K011720 |
| May 23, 2013 | Roche 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 |
JJE | K100853 |
| Apr 24, 2013 | Beckman 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 |
JJE | K112412 |
| Apr 13, 2013 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Product Code 6802413.
Intended for use in the measurement of a variety of chemistry analytes. Terminated |
JJE | K081543 |
| Apr 13, 2013 | Ortho-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 |
JJE | K031924 |
| Apr 13, 2013 | Ortho-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 |
JJE | K031924 K063144 |
| Apr 1, 2013 | Siemens 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 |
JJE | K073604 |
| Apr 1, 2013 | Siemens 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 |
JJE | K073604 |
| Apr 1, 2013 | Siemens 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 |
JJE | K073604 |
| Apr 1, 2013 | Beckman 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 |
JJE | K060256 |
| Apr 1, 2013 | Beckman 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 |
JJE | K023049 |
| Apr 1, 2013 | Beckman 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 |
JJE | None listed |
| Apr 1, 2013 | Beckman 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 |
JJE | K922823 |
| Mar 6, 2013 | Beckman Coulter Inc. Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Terminated |
JJE | K112412 |
| Jan 30, 2013 | Ortho-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 |
JJE | None listed |
| Jan 18, 2013 | Roche Diagnostics Operations, Inc. Roche COBAS INTEGRA 400 and 400 plus Analyzer,
an in vitro diagnostic analyzer. Terminated |
JJE | K951595 |
| Jan 3, 2013 | Horiba 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 |
JJE | K103788 |
| Dec 22, 2012 | Beckman 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 |
JJE | K023049 K060256 +1 |
| Dec 21, 2012 | Radiometer 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 |
JJE | K771444 |
| Dec 4, 2012 | Roche 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 |
JJE | None listed |
| Nov 19, 2012 | Beckman 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 |
JJE | K023764 |
| Nov 19, 2012 | Beckman 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 |
JJE | K023764 |
| Oct 24, 2012 | Beckman 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 |
JJE | K042291 K060256 +1 |
| Oct 12, 2012 | Beckman 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 |
JJE | K042291 K060256 +1 |
| Aug 23, 2012 | Beckman 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 |
JJE | K023764 K042291 |
| Aug 23, 2012 | Beckman 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 |
JJE | K023764 K042291 |
| Aug 23, 2012 | Beckman 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 |
JJE | K023764 K042291 |
| 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 | K112999 |
| Jul 23, 2012 | Ortho-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 |
JJE | K081543 |
| Jul 23, 2012 | Ortho-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 |
JJE | K031924 |
| Jul 23, 2012 | Ortho-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 |
JJE | K031924 |
| Jun 1, 2012 | Ortho-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 |
JJE | K081543 |
| Apr 26, 2012 | Ortho-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 |
JJE | K063144 |
| Apr 26, 2012 | Ortho-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 |
JJE | K063144 |
| Apr 26, 2012 | Ortho-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 |
JJE | K081543 |
| Apr 26, 2012 | Ortho-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 |
JJE | K031924 |
| Apr 26, 2012 | Ortho-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 |
JJE | K083173 |
| Apr 25, 2012 | Siemens 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 |
JJE | K051087 |
| Apr 10, 2012 | Siemens 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 |
JJE | None listed |
| Apr 6, 2012 | Beckman 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 |
JJE | K060256 |
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