510(k) K031924 ยท JIT Calibrator, Secondary
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Aug 7, 2003 |
| Received | Jun 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2025 | Ortho-Clinical Diagnostics, Inc. Brand Name: VITROS
Product Name: VITROS 4600 Chemistry System
Model/Catalog Number: (1) 6802445, (2) 6900440
Software Version: version 3.2 to version 3.8.3 (all available software versions)
Product De Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 Open, Classified |
JJE | None listed |
| Oct 2, 2023 | Ortho-Clinical Diagnostics, Inc. Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic Open, Classified |
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 |
| 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 | 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 9, 2014 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. 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 |
| Jul 2, 2013 | Ortho-Clinical Diagnostics 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890)
Product Usage: For use in the in vitro quantitative, semi-quantitat Terminated |
JJE | None listed |
| Jul 2, 2013 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445)
Product Usage: For use in the 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 13, 2013 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445.
Intended for use in the measurement of a variety of chemistry analytes. Terminated |
JJE | None listed |
| Jul 23, 2012 | Ortho-Clinical Diagnostics VITROS 5,1 FS System Software
For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Terminated |
JJE | None listed |
| Jul 23, 2012 | Ortho-Clinical Diagnostics VITROS 4600 Chemistry System Software
For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Terminated |
JJE | None listed |
| Apr 26, 2012 | Ortho-Clinical Diagnostics VITROS® 4600 Chemistry System, Product Code: 6802445
Product Usage:
For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VI 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.