510(k) K083173 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Dec 22, 2008 |
| Received | Oct 27, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2025 | Ortho-Clinical Diagnostics, INc. Brand Name: VITROS
Product Name: VITROS 3600 Immunodiagnostic System
Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China)
Software Version: version 3.8.0 or higher
Pro Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System (New and Refurbished) Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 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 20, 2020 | Ortho Clinical Diagnostics VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below
Product Code: 6802783, Unique Identifier: 10758750002979 Terminated |
JJE | None listed |
| May 20, 2020 | Ortho Clinical Diagnostics VITROS 3600 Immunodiagnostic System - Refurbished
Product Code: 6802914 Unique Identifier: 10758750007103 Terminated |
JJE | None listed |
| May 20, 2020 | Ortho Clinical Diagnostics VITROS 5600 Integrated System Software Versions 3.3.3 and below
Product Code: 6802413 Unique Identifier: 10758750002740 Terminated |
JJE | None listed |
| May 20, 2020 | Ortho Clinical Diagnostics VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below
Product Code: 6802915 Unique Identifier: 10758750007110 Terminated |
JJE | None listed |
| May 20, 2020 | Ortho Clinical Diagnostics VITROS XT 7600 Integrated System Software Versions 3.5.1
and below
Product Code:6844461 Unique Identifier: 10758750031610 Terminated |
JJE | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS 3600 Immunoassay System-Software V3.3.2 & below
Product Code: 6802783
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical Terminated |
JJE | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below
Product Code: 6802914
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes Terminated |
JJE | None listed |
| Oct 19, 2018 | Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic 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 t Terminated |
JJE | None listed |
| Apr 10, 2018 | Clinical Diagnostic Systems VITROS Immunodiagnostic Products TSH Reagent Pack Terminated |
JLW | None listed |
| Jul 28, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ U Terminated |
JLW | None listed |
| 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 | None listed |
| 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 | 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 |
| 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 | None listed |
| Jul 2, 2013 | Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic System (product code 6802783)
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® 3600 Immunodiagnostic System
Product Usage:
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical inter Terminated |
JJE | None listed |
| Feb 21, 2012 | Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue.
Product Usage:
For use in the in Terminated |
JJE | None listed |
| Feb 21, 2012 | Ortho-Clinical Diagnostics VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600 --- NOTE: VITROS 5600 that are e-Connected are not affected by this issue.
Product Usage:
For use in the in vitr Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.