510(k) K081543 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 23, 2008 |
| Received | Jun 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2025 | Ortho-Clinical Diagnostics, Inc. Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: (1) 6802413, (2) 6802915 Open, Classified |
JJE | None listed |
| Jan 21, 2025 | Ortho-Clinical Diagnostics, INc. Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China)
Software Version: version 3.8.0 or higher
Product D Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System (New and Refurbished) Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 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 |
| May 4, 2023 | Ortho-Clinical Diagnostics, Inc. 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
Micr Open, Classified |
JJE | None listed |
| May 4, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistr Open, Classified |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 5600 Integrated System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 5600 Integrated System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System -Software V3.3.2 & below
Product Code: 6802413
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini Terminated |
JJE | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below
Product Code: 6802915
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analyte Terminated |
JJE | None listed |
| Oct 19, 2018 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Version 3.3.1 & below
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Terminated |
JJE | None listed |
| Aug 15, 2018 | 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,
Catalog Number: 6802413 Terminated |
JLW | None listed |
| Aug 15, 2018 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System- (Refurbished).
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,
Catalog Number: 680291 Terminated |
JLW | None listed |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - TSH Reagent Pack
(10758750000227) 1912997 Open, Classified |
JLW | None listed |
| May 9, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic Terminated |
DIP | None listed |
| Jun 12, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc.
For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively meas Terminated |
DIP | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
| Nov 2, 2015 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products C Terminated |
JIT | None listed |
| 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 | None listed |
| 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 | 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 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 | None listed |
| 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 | None listed |
| Jun 9, 2014 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Terminated |
JJE | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671
VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/35 Terminated |
DIP | None listed |
| Jul 2, 2013 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System (product code 6802413)
Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interes 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 5600 Integrated System, Product Code 6802413.
Intended for use in the measurement of a variety of chemistry analytes. Terminated |
JJE | None listed |
| Jul 23, 2012 | Ortho-Clinical Diagnostics VITROS 5600 Integrated 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 |
| Jun 1, 2012 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System Software Version 1.6 & Below
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical in Terminated |
JJE | None listed |
| Apr 26, 2012 | Ortho-Clinical Diagnostics VITROS® 5600 Chemistry System, Product Code: 6802413
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.