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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)
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Top companies in KHO

DateFirm and productCodeLinked 510(k)
May 22, 2020Tosoh Bioscience Inc
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Terminated
KHONone listed
Feb 11, 2020Tosoh Bioscience Inc
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Terminated
KHONone listed
Feb 20, 2019Ortho-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
KHOK962919
Feb 20, 2019Ortho-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
KHOK962919
Oct 5, 2018Tosoh 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
KHONone listed
Oct 5, 2018Tosoh Bioscience Inc
AIA-900 Analyzer, Product code 022930, 022930R
Terminated
KHONone listed
Sep 28, 2018Tosoh Bioscience Inc
Tosoh AIA-900 immunoassay Analyzer
Terminated
KHONone listed
Sep 28, 2018Tosoh 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
KHONone listed
Sep 28, 2018Tosoh 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
KHONone listed
Sep 28, 2018Tosoh 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
KHONone listed
Aug 23, 2018Tosoh 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
KHONone listed
Sep 28, 2017Tosoh 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
KHONone listed
Jun 11, 2017Tosoh 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
KHONone listed
Jun 11, 2017Tosoh 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
KHONone listed
Mar 22, 2017Tosoh 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
KHONone listed
Jan 27, 2017PerkinElmer 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
KHONone listed
Jan 27, 2017PerkinElmer 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
KHOK090846
Dec 21, 2016PerkinElmer 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
KHOK935047
Dec 21, 2016PerkinElmer 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
KHOK935047
Dec 21, 2016PerkinElmer 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
KHOK935047
Jul 2, 2015Tecan 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
KHONone listed
Jul 2, 2015Tecan 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
KHONone listed
Jul 2, 2015Tecan 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
KHONone listed
Jul 2, 2015Tecan 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
KHONone listed
Jul 2, 2015Tecan 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
KHONone listed
Jan 15, 2015Tecan 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
KHONone listed
Jan 15, 2015Tecan 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
KHONone listed
Jul 30, 2013Tosoh 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
KHOK971103
Feb 28, 2012PerkinElmer 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
KHOK090846
Jan 27, 2012Ortho-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
KHOK962919
Jan 27, 2012Ortho-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
KHOK962919
Nov 15, 2005Ortho-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
KHOK962919

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