510(k) K182063 ยท JFY Enzymatic Method, Creatinine
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2025 | Ortho-Clinical Diagnostics, Inc. Brand Name: VITROS;
Product Name: VITROS XT 7600 Integrated System;
Model/Catalog Number: (1) 6844461, (2) 6272222;
Software Version: version 3.2 to version 3.8.3 (all available software versions);
Pr Open, Classified |
JJE | None listed |
| Jan 21, 2025 | Ortho-Clinical Diagnostics, INc. Brand Name: VITROS
Product Name: VITROS XT 7600 Integrated System
Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)
Software Version: version 3.8.0 or higher
Product Descriptio Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT7600 Integrated System Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System, Catalog No. 6844458 Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System, Catalog No. 6844461 Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System, Catalog No. 6844458 Open, Classified |
JJE | None listed |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System, Catalog No. 6844461 Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System Product Code 6844461 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 XT 7600 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
Open, Classified |
JJE | None listed |
| Jul 19, 2022 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System with Version 3.7.2 and below
Product Code: 6844458 Open, Classified |
JJE | None listed |
| Jul 19, 2022 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System with Version 3.7.2 and below
Product Code: 6844461 Open, Classified |
JJE | None listed |
| Mar 26, 2021 | Ortho-Clinical Diagnostics, INc. VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure. Terminated |
N/A | None listed |
| Jul 20, 2020 | Ortho Clinical Diagnostics VITROS XT3400 Chemistry System, Product code 6844458 Terminated |
JJE | None listed |
| Jul 20, 2020 | Ortho Clinical Diagnostics VITROS XT7600 Integrated System, Product code 6844461 Terminated |
JJE | None listed |
| Jul 13, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS
In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931 Terminated |
JFY | None listed |
| Mar 20, 2019 | Ortho-Clinical Diagnostics VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW
Product Code: 6844461
Product Usage:
INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use i Terminated |
JJE | None listed |
| Mar 11, 2019 | Ortho-Clinical Diagnostics VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658
Product Usage:
The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and Terminated |
JJE | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS XT 7600 Integrated System-Software V3.4.1 & below
Product Code: 6844461
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.