Panels › Clinical Chemistry › Product code KHO · Class 1
Fluorometer, For Clinical Use
Regulation 862.2560
0510(k)s in 12 months (38 all time)
0recalls in 12 months (32 all time)
11recalls that name a 510(k)
Top companies in KHO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2020 | Tosoh Bioscience Inc AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 Terminated |
KHO | None listed |
| Feb 11, 2020 | Tosoh Bioscience Inc AIA-360 Automated Immunoassay Analyzer, Product Code 019945 Terminated |
KHO | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS ECi Immunodiagnostic System Refurbished
Product Code: 6801059
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interes Terminated |
KHO | K962919 |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System
Product Code: 1922814
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, usi Terminated |
KHO | K962919 |
| Oct 5, 2018 | Tosoh Bioscience Inc AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R
Product Usage:
The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoass Terminated |
KHO | None listed |
| Oct 5, 2018 | Tosoh Bioscience Inc AIA-900 Analyzer, Product code 022930, 022930R Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc Tosoh AIA-900 immunoassay Analyzer Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-900Analyzer, Product code 022930, 022930R
The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R
The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sand Terminated |
KHO | None listed |
| Aug 23, 2018 | Tosoh Bioscience Inc AIA-360 Analyzer, product code 019945/019945R
The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry r Terminated |
KHO | None listed |
| Sep 28, 2017 | Tosoh Bioscience Inc AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymet Terminated |
KHO | None listed |
| Jun 11, 2017 | Tosoh Bioscience Inc TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code 022932.
Product Usage:
The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems. Terminated |
KHO | None listed |
| Jun 11, 2017 | Tosoh Bioscience Inc TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930.
Product Usage:
The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that Terminated |
KHO | None listed |
| Mar 22, 2017 | Tosoh Bioscience Inc AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins b Terminated |
KHO | None listed |
| Jan 27, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Spare Disk Remover Module; Product Number: 61001820
Intended for in vitro quantitative and qualitative determination of analytes in body fluids. Terminated |
KHO | None listed |
| Jan 27, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010
Intended for in vitro quantitative and qualitative determination of analytes in body fluids. Terminated |
KHO | K090846 |
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. DELFIA PC with V3.0 Software, Fluorometer, for clinical use
Product Number: 1235-8100
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assa Terminated |
KHO | K935047 |
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use
Product Number: 1235-8110
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perf Terminated |
KHO | K935047 |
| Dec 21, 2016 | PerkinElmer Health Sciences, Inc. AutoDELFIA Plate Processor , Fluorometer, for clinical use
Product Number: 1235-5110
Product Usage:
The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assa Terminated |
KHO | K935047 |
| Jul 2, 2015 | Tecan US, Inc. Infinite 200 in vitro diagnostic.
Product Usage:
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majorit Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite 200 PRO in vitro diagnostic.
Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite M1000 in vitro diagnostic.
Product Usage:
The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite M1000 PRO in vitro diagnostic.
Product Usage:
The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority o Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite F500, in vitro diagnostic.
Product Usage:
The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majo Terminated |
KHO | None listed |
| Jan 15, 2015 | Tecan US, Inc. Infinite 200PRO
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications a Terminated |
KHO | None listed |
| Jan 15, 2015 | Tecan US, Inc. Infinite 200
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and Terminated |
KHO | None listed |
| Jul 30, 2013 | Tosoh Smd Inc AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag
AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Terminated |
KHO | K971103 |
| Feb 28, 2012 | PerkinElmer Life and Analytical Sciences, Wallac, OY Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. Terminated |
KHO | K090846 |
| Jan 27, 2012 | Ortho-Clinical Diagnostics VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that hav Terminated |
KHO | K962919 |
| Jan 27, 2012 | Ortho-Clinical Diagnostics VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have So Terminated |
KHO | K962919 |
| Nov 15, 2005 | Ortho-Clinical Diagnostics Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Rea Terminated |
KHO | K962919 |
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