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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)
Apr 6, 2012Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoa
Terminated
JJEK023049
Apr 6, 2012Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF Wash Buffer REF 81907, Part Number: A45142, Access 2 APF Wash Buffer II REF A1
Terminated
JJENone listed
Apr 6, 2012Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A19889, Access APF Wash Buffer REF 81907, Part Number: A45144, Access APF Wash Buffer II REF A16792.
Terminated
JJEK922823
Mar 16, 2012Roche Diagnostics Operations, Inc.
Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
Terminated
JJEK961481
Feb 21, 2012Ortho-Clinical Diagnostics
VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600 --- NOTE: VITROS 5600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitr
Terminated
JJEK083173
Feb 21, 2012Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in
Terminated
JJEK083173
Feb 7, 2012Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use
Terminated
JJEK011720
Feb 7, 2012Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU2700 Clinical Chemistry Analyzer . The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use
Terminated
JJEK003721
Feb 7, 2012Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU
Terminated
JJEK961274
Feb 7, 2012Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) Clinical Chemistry Analyzer, AU480 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are ful
Terminated
JJEK003721
K011720 +2
Jan 30, 2012Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260 UniCel DxC 600i, SYNCHRON Access Clinical Systems Part Numbers: A25656 Uni
Terminated
JJEK023764
Jan 30, 2012Beckman Coulter Inc.
Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number: 81600N Access Immunoassay Systems LXi 725 Part Number: 386200 Subsequent Product Codes: JGS The Access/DxI Imm
Terminated
JJEK922823
Jan 26, 2012Ortho-Clinical Diagnostics
enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical D
Terminated
JJEK063144
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) s
Terminated
JJEK051087
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system
Terminated
JJEK051087
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system
Terminated
JJEK051087
Jan 11, 2012Beckman Coulter Inc.
UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-control
Terminated
JJENone listed
Nov 30, 2011Roche Diagnostics Operations, Inc.
cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or
Terminated
JJENone listed
Nov 30, 2011Roche Diagnostics Operations, Inc.
Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured pho
Terminated
JJEK071211
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the
Terminated
JJEK950958
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed fo
Terminated
JJEK950958
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the
Terminated
JJEK926060
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for t
Terminated
JJEK926060
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX5 Delta Clinical System Part #: 468243 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed fo
Terminated
JJEK950958
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX5 Clinical System Part #: 759300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the
Terminated
JJEK881495
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for t
Terminated
JJEK904220
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed fo
Terminated
JJEK950958
Oct 27, 2011Beckman Coulter Inc.
SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the
Terminated
JJEK881498
Oct 21, 2011Hamilton Co
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bo
Terminated
JJEK943493
Oct 19, 2011Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Terminated
JJEK081643
Oct 12, 2011Siemens Healthcare Diagnostics, Inc.
Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL
Terminated
JJEK081683
Oct 7, 2011Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplic
Terminated
JJEK051087
Aug 19, 2011Siemens Healthcare Diagnostics, Inc.
Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma an
Terminated
JJEK860021
Jun 28, 2011Beckman Coulter Inc.
Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software version 4.3
Terminated
JJEK042291
Jun 28, 2011Beckman Coulter Inc.
Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
Terminated
JJEK023764
Jun 23, 2011Beckman Coulter Inc.
Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinica
Terminated
JJEK042291
K060256
May 6, 2011Beckman Coulter Inc.
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Terminated
JJEK023049
May 6, 2011Beckman Coulter Inc.
Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Terminated
JJEK011213
May 6, 2011Beckman Coulter Inc.
Synchron LX20, Part Number: 466200. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Terminated
JJEK965240
Apr 26, 2011Beckman Coulter Inc.
Synchron LX 20 The Synchron LX Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic
Terminated
JJEK011213
Apr 26, 2011Beckman Coulter Inc.
Synchron LX 20 PRO The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic
Terminated
JJEK965240
Apr 13, 2011Beckman Coulter Inc.
UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A648
Terminated
JJEK042291
K060256
Apr 12, 2011Beckman Coulter Inc.
SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration
Terminated
JJEK023049
Apr 12, 2011Beckman Coulter Inc.
UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration
Terminated
JJEK060256
Apr 12, 2011Beckman Coulter Inc.
Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found i
Terminated
JJEK922826
Apr 12, 2011Beckman Coulter Inc.
Liquid Waste Bottle To store waste material from completed assays.
Terminated
JJENone listed
Apr 11, 2011Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, DxC860i: A64935, DxC 880i: A59102 The DxI Immunoassay System is an in vitro diag
Terminated
JJEK023764
K042291
Apr 11, 2011Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quant
Terminated
JJEK023764
K042291
Apr 11, 2011Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in
Terminated
JJEK023764
K042291
Mar 28, 2011Ortho-Clinical Diagnostics
The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File d
Terminated
JJENone listed

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