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) |
|---|---|---|---|
| Dec 13, 2010 | Beckman Coulter Inc. Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N;
Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Ac Terminated |
JJE | K023764 K060256 +1 |
| Oct 21, 2010 | Siemens 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 |
JJE | K051087 |
| Oct 18, 2010 | Medica Corporation EasyRA Cuvette Segment 1, P/N 007000-001
(In Vitro Diagnostic )
EasyRA Cuvette Segments included in the following Kits:
EasyRA Cuvettes, REF 10700-4
Startup Kit - Chemistry, REF 10990
Startup Kit - C Terminated |
JJE | K070057 K072249 |
| Sep 30, 2010 | Beckman Coulter Inc. UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software
version: 4.9.01
The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry Terminated |
JJE | K060256 |
| Sep 23, 2010 | Abbott Laboratories, Inc ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL
Product List Number, Part # or Model: 01L86-01
In Vitro Diagnostic use only. The Abbott ARC Terminated |
JJE | None listed |
| Sep 20, 2010 | Beckman Coulter Inc. Closed Tube Aliquotter (CTA) for UniCel
DxC 600i, Part Number: A25637, Domestic; A25633, International
The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry Terminated |
JJE | K060256 |
| Sep 20, 2010 | Beckman Coulter Inc. Unicel Synchron Clinical Systems
Closed Tube Aliquotter (CTA) for Synchron LXi 725, Part Number: 388982, Domestic; 389695, International
The UniCel Synchron Clinical Systems are fully automated, compu Terminated |
JJE | K023049 |
| Sep 15, 2010 | Siemens 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 |
JJE | K051087 |
| Aug 2, 2010 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use. Terminated |
JJE | K051087 |
| Jun 24, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000/2500 Chemiluminescent Substrate Module
For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer. Terminated |
JJE | K970227 |
| Apr 9, 2010 | Abbott Laboratories, Inc ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip Terminated |
JJE | K983212 |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Diluent catalog number K835 Terminated |
JJE | K051087 |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 Terminated |
JJE | K051087 |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Standard A catalog number K820 Terminated |
JJE | K051087 |
| Mar 8, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. Terminated |
JJE | K051087 |
| Mar 5, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista LOCI Reaction Vessel Terminated |
JJE | K051087 |
| Mar 4, 2010 | Beckman Coulter Inc. Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell.
PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel D Terminated |
JJE | K042291 K060256 |
| Mar 2, 2010 | Beckman Coulter Inc. Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
Intended to be used with Terminated |
JJE | K023764 K060256 |
| Feb 25, 2010 | Beckman Coulter Inc. UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1.
In vitro diagnostic device us Terminated |
JJE | K023764 K060256 |
| Nov 9, 2009 | Abbott Laboratories, Inc ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit.
ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiomet Terminated |
JJE | K983212 |
| Sep 30, 2009 | Abbott Laboratories ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott L Terminated |
JJE | None listed |
| Sep 30, 2009 | Abbott Laboratories AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09.
To be used only for cleaning and inhibition of fou Terminated |
JJE | K974651 |
| Sep 29, 2009 | Siemens 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 |
JJE | K051087 |
| May 27, 2009 | Abbott Laboratories ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01.
The ARCHITECT Reaction Vessels are Terminated |
JJE | None listed |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001.
Is a fully automatic, computerized chemistry analyze Terminated |
JJE | K953239 |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284522001.
Is a fully automatic, computerized chemistry analyze Terminated |
JJE | K953239 |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001.
Is a fully automatic, computerized chemistry anal Terminated |
JJE | K953239 |
| Apr 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001.
Is a fully automatic, computerized chemistry ana Terminated |
JJE | K953239 |
| Mar 24, 2009 | Roche Diagnostics Corp. Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN.
Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific pro Terminated |
JJE | K071211 |
| Jan 13, 2009 | Dade Behring, Inc. Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.
The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that Terminated |
JJE | K073604 |
| Oct 22, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001. Terminated |
JJE | K961481 |
| Sep 21, 2008 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System Terminated |
JJE | K023764 |
| Sep 19, 2008 | Abbott Laboratories ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by p Terminated |
JJE | None listed |
| Aug 20, 2008 | Beckman Coulter Inc Beckman Coulter UniCel Dxl 800 Access Immunoassay System;
Part Number: 973100
With: UniCel Dxl 800 Modification (MOD ID 10027)
and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnosti Terminated |
JJE | K023764 |
| Aug 20, 2008 | Beckman Coulter Inc Access Power Supply Assembly Sled
Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use. Terminated |
JJE | K023049 K060256 +1 |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001.
Intended for qualitative and quantitative in vitro determinations using a wide variety o Terminated |
JJE | K953239 |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 03284522001.
Intended for qualitative and quantitative in vitro determinations using a wide v Terminated |
JJE | K953239 |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001.
Intended for qualitative and quantitative in vitro determinations usi Terminated |
JJE | K961481 |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001.
Intended for qualitative and quantitative in vitro determinations using a wid Terminated |
JJE | K953239 |
| Aug 13, 2008 | Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001.
Intended for qualitative and quantitative in vitro determinations using a wi Terminated |
JJE | K953239 |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc. Terminated |
JJE | K042291 |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc. Terminated |
JJE | K042291 |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc. Terminated |
JJE | K042291 |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600i, Part Numbers: A25638, A25639, Beckman Coulter, Inc. Terminated |
JJE | K060256 |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc. Terminated |
JJE | K042291 |
| May 24, 2008 | Beckman Coulter Inc Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc. Terminated |
JJE | K023049 |
| May 24, 2008 | Beckman Coulter Inc Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc. Terminated |
JJE | K011213 |
| May 24, 2008 | Beckman Coulter Inc Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc. Terminated |
JJE | K965240 |
| Nov 7, 2007 | Abbott Laboratories, Inc ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laborato Terminated |
JJE | None listed |
| Nov 7, 2007 | Abbott Laboratories, Inc ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratori Terminated |
JJE | K980367 |
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