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) |
|---|---|---|---|
| Jan 14, 2015 | Ortho-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 |
JJE | K031924 K063144 +2 |
| Jan 2, 2015 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) Terminated |
JJE | K052007 |
| Dec 23, 2014 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XP Immunoassay System (including refurbished)
Professional use in a laboratory for in vitro diagnostic tests. Terminated |
JJE | K041133 |
| Dec 23, 2014 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur (including refurbished)
Professional use in a laboratory for in vitro diagnostic tests. Terminated |
JJE | K041133 |
| Dec 20, 2014 | Siemens 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 |
JJE | K051087 |
| Nov 14, 2014 | Siemens 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 |
JJE | None listed |
| Nov 6, 2014 | Beckman 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 |
JJE | K060256 |
| Nov 6, 2014 | Beckman 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 |
JJE | K121214 |
| Oct 16, 2014 | Ortho-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 |
JJE | K081543 |
| Oct 16, 2014 | Ortho-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 |
JJE | K031924 K063144 |
| Sep 29, 2014 | Siemens 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 |
JJE | K041133 |
| Sep 29, 2014 | Siemens 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 |
JJE | K041133 |
| Sep 23, 2014 | Beckman 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 |
JJE | K023764 K042291 +1 |
| Sep 18, 2014 | Siemens 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 |
JJE | K041133 |
| Sep 18, 2014 | Siemens 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 |
JJE | K041133 |
| Aug 26, 2014 | Siemens 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 |
JJE | K130276 |
| Aug 1, 2014 | Ortho-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 |
JJE | K081543 |
| Aug 1, 2014 | Ortho-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 |
JJE | K031924 K063144 |
| Aug 1, 2014 | Ortho-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 |
JJE | K083173 |
| Jul 30, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. Terminated |
JJE | K073604 K112999 +1 |
| Jun 26, 2014 | Siemens 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 |
JJE | None listed |
| Jun 25, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901.
Designed to automate sample handling and processing in the clinical laboratory. Terminated |
JJE | None listed |
| Jun 14, 2014 | Roche 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 |
JJE | K060373 |
| Jun 14, 2014 | Roche 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 |
JJE | K060373 |
| Jun 14, 2014 | Roche 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 |
JJE | K961481 |
| Jun 10, 2014 | Ortho-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 |
JJE | K063144 |
| Jun 9, 2014 | Beckman 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 |
JJE | K042291 |
| Jun 9, 2014 | Ortho-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 |
JJE | K031924 K063144 |
| Jun 9, 2014 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Terminated |
JJE | K081543 |
| Jun 9, 2014 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Terminated |
JJE | K031924 |
| Jun 9, 2014 | Ortho-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 |
JJE | K063144 |
| Jun 9, 2014 | Siemens 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 |
JJE | K051087 |
| Jun 2, 2014 | Ortho-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 |
JJE | K063144 |
| May 13, 2014 | Siemens 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 |
JJE | K971418 |
| Apr 28, 2014 | Ortho-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 |
JJE | K962235 |
| Apr 28, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY Terminated |
JJE | K962235 |
| Apr 10, 2014 | Roche 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 |
JJE | K100853 |
| Apr 2, 2014 | Siemens 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 |
JJE | K970227 |
| Feb 16, 2014 | Beckman 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 |
JJE | K023764 |
| Feb 16, 2014 | Beckman 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 |
JJE | K922823 |
| Feb 9, 2014 | Siemens 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 |
JJE | K990346 |
| Feb 9, 2014 | Ortho-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 |
JJE | None listed |
| Feb 9, 2014 | Ortho-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 |
JJE | None listed |
| Jan 28, 2014 | Siemens 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 |
JJE | K051087 |
| Jan 21, 2014 | Siemens 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 |
JJE | K990346 |
| Dec 16, 2013 | Beckman 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 |
JJE | None listed |
| Dec 2, 2013 | Siemens 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 |
JJE | K051087 |
| Nov 14, 2013 | Beckman 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 |
JJE | K922823 |
| Nov 5, 2013 | Beckman 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 |
JJE | K112412 K961274 +1 |
| Nov 5, 2013 | Beckman 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 |
JJE | K003721 K011720 +2 |
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