510(k) K063144 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 13, 2006 |
| Received | Oct 16, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 4600 Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 4600 Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Terminated |
JIX | None listed |
| Oct 19, 2018 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Version 3.0 & below
For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the anal Terminated |
JJE | None listed |
| Oct 19, 2018 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Version 3.3.1 & below
For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the anal Terminated |
JJE | None listed |
| Apr 26, 2017 | Ortho-Clinical Diagnostics enGen Track System with TCAutomation Software Version 4.2 Terminated |
JJE | None listed |
| Mar 8, 2017 | Ortho-Clinical Diagnostics enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD Terminated |
JJE | None listed |
| Sep 7, 2016 | Ortho-Clinical Diagnostics enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Mod Terminated |
JJE | None listed |
| Jul 8, 2016 | Ortho-Clinical Diagnostics enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD Terminated |
JJE | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jun 6, 2013 | Ortho-Clinical Diagnostics Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413
Product Usage: The CM/RT incubator processes Microslide reagents with the following V Terminated |
JJE | None listed |
| Apr 13, 2013 | Ortho-Clinical Diagnostics VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890.
Intended for use in the measurement of a variety of chemistry analytes. Terminated |
JJE | None listed |
| Apr 26, 2012 | Ortho-Clinical Diagnostics VITROS® 5,1 FS System, Product Codes: 6801375 & 6801890
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of Terminated |
JJE | None listed |
| Apr 26, 2012 | Ortho-Clinical Diagnostics VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative me Terminated |
JJE | None listed |
| 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 | None listed |
| Aug 16, 2007 | Ortho-Clinical Diagnostics VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375. Terminated |
JJE | None listed |
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