Panels › Clinical Chemistry › Product code DOP · Class 1
Mass Spectrometer, Clinical Use
Regulation 862.2860
0510(k)s in 12 months (10 all time)
0recalls in 12 months (16 all time)
0recalls that name a 510(k)
Top companies in DOP
| Company | 510(k)s | Recalls |
|---|---|---|
| AB SCIEX | 0 | 12 |
| Finnigan Corp. | 3 | 0 |
| The Perkin-Elmer Corp. | 2 | 0 |
| Agilent Technologies, Inc. | 0 | 1 |
| Airspec , Ltd. | 1 | 0 |
| Allied Healthcare Products, Inc. | 1 | 0 |
| Europa Scientific, Ltd. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Pdz-Europa , Ltd. | 1 | 0 |
| PerkinElmer Health Sciences Canada, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2023 | AB Sciex, LLC Citrine Triple Quad Mass Spectrometer, Part Number 5063684 Open, Classified |
DOP | None listed |
| Oct 5, 2023 | AB Sciex, LLC Citrine QTRAP Mass Spectrometer, Part Number 5063685 Open, Classified |
DOP | None listed |
| Oct 5, 2023 | AB Sciex, LLC 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 Open, Classified |
DOP | None listed |
| Oct 5, 2023 | AB Sciex, LLC API3200MD Mass Spectrometer, Part Number 4466230 Open, Classified |
DOP | None listed |
| Oct 4, 2021 | AB SCIEX Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288 Terminated |
DOP | None listed |
| Feb 1, 2021 | Thermo Fisher Scientific Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Terminated |
DOP | None listed |
| Sep 24, 2018 | PerkinElmer Health Sciences Canada, Inc. PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Pa Terminated |
DOP | None listed |
| Aug 15, 2018 | Agilent Technologies, Inc. MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420
Product Usage:
A mass spectrometer for clinical use is a device int Terminated |
DOP | None listed |
| Sep 9, 2016 | Thermo Finnigan LLC Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1.
In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human Terminated |
DOP | None listed |
| Aug 12, 2016 | Ab Sciex AB SCIEX QTRAP 4500MD LC/MS/MS System
Mass Spectrometer for In-Vitro Diagnostic Use.
Instrument Part Number (REF): 5031231
3200MD series and 4500MD series are mass spectrometers intended to identify Terminated |
DOP | None listed |
| Aug 12, 2016 | Ab Sciex AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use.
Instrument Part Number (REF): 5031257
3200MD series and 4500MD series are mass spectrometers intended to i Terminated |
DOP | None listed |
| Aug 12, 2016 | Ab Sciex AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use.
Instrument Part Number (REF): 5024500
3200MD series and 4500MD series are mass spectrometers intended to identify Terminated |
DOP | None listed |
| Aug 12, 2016 | Ab Sciex AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic
Instrument Part Number (REF): 5024501
3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compoun Terminated |
DOP | None listed |
| Apr 29, 2016 | Ab Sciex Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP LC/MS/MS System, Instrument Part Number: 50 Terminated |
DOP | None listed |
| Mar 25, 2016 | Ab Sciex AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231.
Mass spectrometers for in vitro diagnostic use only. Terminated |
DOP | None listed |
| Sep 8, 2014 | Ab Sciex AB SCIEX API 3200MD" LC/MS/MS System with software:
MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens
Part Number 502 Terminated |
DOP | None listed |
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