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) |
|---|---|---|---|
| May 17, 2016 | Beckman Coulter Inc. Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentra Terminated |
JJE | K922823 |
| May 6, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers.
This system is intended for professional use in a laboratory environ Terminated |
JJE | K041133 |
| Apr 6, 2016 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No Terminated |
JJE | K081543 |
| Apr 6, 2016 | Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VI Terminated |
JJE | K083173 |
| Mar 17, 2016 | Ortho-Clinical Diagnostics enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known a Terminated |
JJE | K063144 |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifi Terminated |
JJE | K031924 K063144 |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD.
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative meas Terminated |
JJE | K081543 |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD.
Product Usage:
For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for Terminated |
JJE | K031924 K063144 |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD.
Product Usage:
For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete Terminated |
JJE | K922072 |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD.
Product Usag Terminated |
JJE | K922072 |
| Feb 19, 2016 | Horiba Instruments Inc Pentra C400 (version 1.1.2 or lower)
The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedu Terminated |
JJE | None listed |
| Feb 19, 2016 | Horiba Instruments Inc ABX Pentra 400 (version 5.0.8 or lower)
The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical proc Terminated |
JJE | None listed |
| Feb 16, 2016 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110.
Intended for use in the in vitro measurement of a variety of analytes of clinical interest. Terminated |
JJE | K081543 |
| Feb 13, 2016 | Bio-Rad Laboratories, Inc. EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic
Product Usage:
EVOLIS Microplate System is a 4 plate fully integrated microplate p Terminated |
JJE | None listed |
| Feb 4, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538
Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a t Terminated |
JJE | K990346 |
| Jan 13, 2016 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Terminated |
JJE | K031924 K063144 |
| Jan 13, 2016 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD.
Product Usage:
The VITROS 4600 Chemistry System is intended Terminated |
JJE | K031924 K063144 |
| Jan 13, 2016 | Ortho-Clinical Diagnostics VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD.
Product Usage:
For use in th Terminated |
JJE | K081543 |
| Jan 13, 2016 | Ortho-Clinical Diagnostics VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD.
Product Usage:
For use in th Terminated |
JJE | K083173 |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension RxL Max HM STM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the avai Terminated |
JJE | K112999 |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension RxL Max w/o HM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the avail Terminated |
JJE | K112999 |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension EXL with LM STM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the ava Terminated |
JJE | K130276 |
| Dec 22, 2015 | Siemens Healthcare Diagnostics Inc. Reagent Management System (RMS)
Dimension EXL with LM
Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the availab Terminated |
JJE | K130276 |
| Nov 5, 2015 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, U Terminated |
JJE | K031924 K063144 |
| Sep 9, 2015 | Abbott Laboratories, Inc ARCHITECT i2000SR System
The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemilumine Terminated |
JJE | K980367 |
| Sep 2, 2015 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, U Terminated |
JJE | K031924 |
| Jul 22, 2015 | Abbott Laboratories ARCHITECT c8000 System List Number 01G06-98
Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing Terminated |
JJE | K980367 |
| Jul 9, 2015 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Terminated |
JJE | K051087 |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Triglycerides GPO.
In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems Terminated |
JJE | K921661 |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Creatinine Plus.
Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. Terminated |
JJE | K953239 |
| Jun 9, 2015 | Ortho-Clinical Diagnostics VITROS 5600 Chemistry System, Software Version 3.2 & Below.
Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Terminated |
JJE | K081543 |
| Jun 9, 2015 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Software Version 3.2 & Below.
Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Terminated |
JJE | K081543 |
| Jun 8, 2015 | Ortho-Clinical Diagnostics Assay Data Disk (ADD), All DRV versions that support product within expiry dating
Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Ass Terminated |
JJE | K063144 |
| Jun 8, 2015 | Abbott Laboratories Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room tem Terminated |
JJE | K980367 |
| Jun 8, 2015 | Ortho-Clinical Diagnostics enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (23 Terminated |
JJE | K063144 |
| Jun 8, 2015 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below
Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium ( Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle Kit, Catalog#10386287.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pla Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water Feed Kit, Catalog#10288216,#10389714.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urin Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Direct Water feed Kit, Catalog#10373222 Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Accessory Kit, Catalog#10282965, #10373217,#10286080.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasm Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle, Catalog#10291587.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine sam Terminated |
JJE | K970277 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water bottles, Catalog#10380062, #10291586.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pl Terminated |
JJE | K970227 |
| May 14, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. Terminated |
JJE | K073604 K112999 +1 |
| May 13, 2015 | The Binding Site Group, Ltd. Optilite Analyser, Product Code: IE700
Product Usage:
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that m Terminated |
JJE | K110035 |
| Apr 25, 2015 | Ortho-Clinical Diagnostics Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890 Terminated |
JJE | K031924 K063144 |
| Feb 9, 2015 | Radiometer America Inc ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Terminated |
JJE | K120197 |
| Jan 20, 2015 | Ortho-Clinical Diagnostics VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System
1) VITROS 4600 - in vitro quantitative measurem Terminated |
JJE | K031924 K063144 |
| Jan 15, 2015 | Abbott Laboratories, Inc ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette Terminated |
JJE | K980367 |
| Jan 14, 2015 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics.
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analyte Terminated |
JJE | K031924 K063144 +2 |
| Jan 14, 2015 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics.
The VITROS 4600 Chemistry System is intended for use in the in vitro qua Terminated |
JJE | K031924 K063144 +2 |
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