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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)
Jan 14, 2015Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of
Terminated
JJEK031924
K063144 +2
Jan 2, 2015Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Terminated
JJEK052007
Dec 23, 2014Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Terminated
JJEK041133
Dec 23, 2014Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Terminated
JJEK041133
Dec 20, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing,
Terminated
JJEK051087
Nov 14, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041
Terminated
JJENone listed
Nov 6, 2014Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantita
Terminated
JJEK060256
Nov 6, 2014Beckman Coulter Inc.
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitat
Terminated
JJEK121214
Oct 16, 2014Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using V
Terminated
JJEK081543
Oct 16, 2014Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a vari
Terminated
JJEK031924
K063144
Sep 29, 2014Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for i
Terminated
JJEK041133
Sep 29, 2014Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in v
Terminated
JJEK041133
Sep 23, 2014Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human b
Terminated
JJEK023764
K042291 +1
Sep 18, 2014Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 103293
Terminated
JJEK041133
Sep 18, 2014Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403,
Terminated
JJEK041133
Aug 26, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 1048689
Terminated
JJEK130276
Aug 1, 2014Ortho-Clinical Diagnostics
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Sl
Terminated
JJEK081543
Aug 1, 2014Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical
Terminated
JJEK031924
K063144
Aug 1, 2014Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic
Terminated
JJEK083173
Jul 30, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Terminated
JJEK073604
K112999 +1
Jun 26, 2014Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use
Terminated
JJENone listed
Jun 25, 2014Siemens Healthcare Diagnostics, Inc.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
Terminated
JJENone listed
Jun 14, 2014Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended f
Terminated
JJEK060373
Jun 14, 2014Roche Diagnostics Operations, Inc.
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended f
Terminated
JJEK060373
Jun 14, 2014Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully autom
Terminated
JJEK961481
Jun 10, 2014Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemis
Terminated
JJEK063144
Jun 9, 2014Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i,
Terminated
JJEK042291
Jun 9, 2014Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Terminated
JJEK031924
K063144
Jun 9, 2014Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Terminated
JJEK081543
Jun 9, 2014Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Terminated
JJEK031924
Jun 9, 2014Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and
Terminated
JJEK063144
Jun 9, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems.
Terminated
JJEK051087
Jun 2, 2014Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest
Terminated
JJEK063144
May 13, 2014Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Terminated
JJEK971418
Apr 28, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
Terminated
JJEK962235
Apr 28, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Terminated
JJEK962235
Apr 10, 2014Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Terminated
JJEK100853
Apr 2, 2014Siemens Medical Solutions Diagnostics
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine
Terminated
JJEK970227
Feb 16, 2014Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various
Terminated
JJEK023764
Feb 16, 2014Beckman Coulter Inc.
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte con
Terminated
JJEK922823
Feb 9, 2014Siemens Healthcare Diagnostics, Inc.
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throug
Terminated
JJEK990346
Feb 9, 2014Ortho-Clinical Diagnostics
enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement
Terminated
JJENone listed
Feb 9, 2014Ortho-Clinical Diagnostics
enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quanti
Terminated
JJENone listed
Jan 28, 2014Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or
Terminated
JJEK051087
Jan 21, 2014Siemens Healthcare Diagnostics, Inc.
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Terminated
JJEK990346
Dec 16, 2013Beckman Coulter Inc.
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyt
Terminated
JJENone listed
Dec 2, 2013Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in
Terminated
JJEK051087
Nov 14, 2013Beckman Coulter Inc.
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various an
Terminated
JJEK922823
Nov 5, 2013Beckman Coulter Inc.
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Terminated
JJEK112412
K961274 +1
Nov 5, 2013Beckman Coulter Inc.
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Terminated
JJEK003721
K011720 +2

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