ClearanceBrief
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)
Get daily alerts for JJESample briefCSV

Top companies in JJE

DateFirm and productCodeLinked 510(k)
Dec 13, 2010Beckman 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
JJEK023764
K060256 +1
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
JJEK051087
Oct 18, 2010Medica 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
JJEK070057
K072249
Sep 30, 2010Beckman 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
JJEK060256
Sep 23, 2010Abbott 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
JJENone listed
Sep 20, 2010Beckman 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
JJEK060256
Sep 20, 2010Beckman 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
JJEK023049
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
JJEK051087
Aug 2, 2010Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.
Terminated
JJEK051087
Jun 24, 2010Siemens 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
JJEK970227
Apr 9, 2010Abbott 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
JJEK983212
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Diluent catalog number K835
Terminated
JJEK051087
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825
Terminated
JJEK051087
Mar 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista V-LYTE Fluids: Standard A catalog number K820
Terminated
JJEK051087
Mar 8, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Terminated
JJEK051087
Mar 5, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista LOCI Reaction Vessel
Terminated
JJEK051087
Mar 4, 2010Beckman 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
JJEK042291
K060256
Mar 2, 2010Beckman 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
JJEK023764
K060256
Feb 25, 2010Beckman 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
JJEK023764
K060256
Nov 9, 2009Abbott 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
JJEK983212
Sep 30, 2009Abbott 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
JJENone listed
Sep 30, 2009Abbott 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
JJEK974651
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
JJEK051087
May 27, 2009Abbott 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
JJENone listed
Apr 10, 2009Roche 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
JJEK953239
Apr 10, 2009Roche 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
JJEK953239
Apr 10, 2009Roche 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
JJEK953239
Apr 10, 2009Roche 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
JJEK953239
Mar 24, 2009Roche 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
JJEK071211
Jan 13, 2009Dade 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
JJEK073604
Oct 22, 2008Roche Diagnostics Corp.
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Terminated
JJEK961481
Sep 21, 2008Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
Terminated
JJEK023764
Sep 19, 2008Abbott 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
JJENone listed
Aug 20, 2008Beckman 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
JJEK023764
Aug 20, 2008Beckman 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
JJEK023049
K060256 +1
Aug 13, 2008Roche 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
JJEK953239
Aug 13, 2008Roche 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
JJEK953239
Aug 13, 2008Roche 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
JJEK961481
Aug 13, 2008Roche 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
JJEK953239
Aug 13, 2008Roche 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
JJEK953239
May 24, 2008Beckman Coulter Inc
UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc.
Terminated
JJEK042291
May 24, 2008Beckman Coulter Inc
UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc.
Terminated
JJEK042291
May 24, 2008Beckman Coulter Inc
UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc.
Terminated
JJEK042291
May 24, 2008Beckman Coulter Inc
UniCel DxC 600i, Part Numbers: A25638, A25639, Beckman Coulter, Inc.
Terminated
JJEK060256
May 24, 2008Beckman Coulter Inc
UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc.
Terminated
JJEK042291
May 24, 2008Beckman Coulter Inc
Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc.
Terminated
JJEK023049
May 24, 2008Beckman Coulter Inc
Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc.
Terminated
JJEK011213
May 24, 2008Beckman Coulter Inc
Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc.
Terminated
JJEK965240
Nov 7, 2007Abbott 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
JJENone listed
Nov 7, 2007Abbott 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
JJEK980367

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.