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) |
|---|---|---|---|
| Apr 6, 2012 | Beckman 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 |
JJE | K023049 |
| Apr 6, 2012 | Beckman 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 |
JJE | None listed |
| Apr 6, 2012 | Beckman 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 |
JJE | K922823 |
| Mar 16, 2012 | Roche 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 |
JJE | K961481 |
| Feb 21, 2012 | Ortho-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 |
JJE | K083173 |
| Feb 21, 2012 | Ortho-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 |
JJE | K083173 |
| Feb 7, 2012 | Beckman 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 |
JJE | K011720 |
| Feb 7, 2012 | Beckman 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 |
JJE | K003721 |
| Feb 7, 2012 | Beckman 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 |
JJE | K961274 |
| Feb 7, 2012 | Beckman 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 |
JJE | K003721 K011720 +2 |
| Jan 30, 2012 | Beckman 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 |
JJE | K023764 |
| Jan 30, 2012 | Beckman 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 |
JJE | K922823 |
| Jan 26, 2012 | Ortho-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 |
JJE | K063144 |
| Jan 11, 2012 | Siemens 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 |
JJE | K051087 |
| Jan 11, 2012 | Siemens 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 |
JJE | K051087 |
| Jan 11, 2012 | Siemens 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 |
JJE | K051087 |
| Jan 11, 2012 | Beckman 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 |
JJE | None listed |
| Nov 30, 2011 | Roche 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 |
JJE | None listed |
| Nov 30, 2011 | Roche 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 |
JJE | K071211 |
| Oct 27, 2011 | Beckman 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 |
JJE | K950958 |
| Oct 27, 2011 | Beckman 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 |
JJE | K950958 |
| Oct 27, 2011 | Beckman 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 |
JJE | K926060 |
| Oct 27, 2011 | Beckman 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 |
JJE | K926060 |
| Oct 27, 2011 | Beckman 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 |
JJE | K950958 |
| Oct 27, 2011 | Beckman 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 |
JJE | K881495 |
| Oct 27, 2011 | Beckman 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 |
JJE | K904220 |
| Oct 27, 2011 | Beckman 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 |
JJE | K950958 |
| Oct 27, 2011 | Beckman 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 |
JJE | K881498 |
| Oct 21, 2011 | Hamilton 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 |
JJE | K943493 |
| Oct 19, 2011 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges Terminated |
JJE | K081643 |
| Oct 12, 2011 | Siemens 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 |
JJE | K081683 |
| Oct 7, 2011 | Siemens 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 |
JJE | K051087 |
| Aug 19, 2011 | Siemens 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 |
JJE | K860021 |
| Jun 28, 2011 | Beckman Coulter Inc. Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software version 4.3 Terminated |
JJE | K042291 |
| Jun 28, 2011 | Beckman Coulter Inc. Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3 Terminated |
JJE | K023764 |
| Jun 23, 2011 | Beckman 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 |
JJE | K042291 K060256 |
| May 6, 2011 | Beckman 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 |
JJE | K023049 |
| May 6, 2011 | Beckman 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 |
JJE | K011213 |
| May 6, 2011 | Beckman 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 |
JJE | K965240 |
| Apr 26, 2011 | Beckman 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 |
JJE | K011213 |
| Apr 26, 2011 | Beckman 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 |
JJE | K965240 |
| Apr 13, 2011 | Beckman 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 |
JJE | K042291 K060256 |
| Apr 12, 2011 | Beckman 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 |
JJE | K023049 |
| Apr 12, 2011 | Beckman 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 |
JJE | K060256 |
| Apr 12, 2011 | Beckman 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 |
JJE | K922826 |
| Apr 12, 2011 | Beckman Coulter Inc. Liquid Waste Bottle
To store waste material from completed assays. Terminated |
JJE | None listed |
| Apr 11, 2011 | Beckman 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 |
JJE | K023764 K042291 |
| Apr 11, 2011 | Beckman 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 |
JJE | K023764 K042291 |
| Apr 11, 2011 | Beckman 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 |
JJE | K023764 K042291 |
| Mar 28, 2011 | Ortho-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 |
JJE | None listed |
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