ClearanceBrief
Company ยท US

Ab Sciex

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2017. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DOPMass Spectrometer, Clinical Use12
PSL25-Oh-Vitamin D Mass Spectrometry Test System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 18, 2017DEN170019Vitamin D 200M Assay for the Topaz System
Ab Sciex, LLC
PSL

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 5, 2023AB Sciex, LLC
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Open, Classified
DOPNone listed
Oct 5, 2023AB Sciex, LLC
Citrine QTRAP Mass Spectrometer, Part Number 5063685
Open, Classified
DOPNone listed
Oct 5, 2023AB Sciex, LLC
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Open, Classified
DOPNone listed
Oct 5, 2023AB Sciex, LLC
API3200MD Mass Spectrometer, Part Number 4466230
Open, Classified
DOPNone listed
Oct 4, 2021AB 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
DOPNone listed
Aug 12, 2016Ab 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
DOPNone listed
Aug 12, 2016Ab 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
DOPNone listed
Aug 12, 2016Ab 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
DOPNone listed
Aug 12, 2016Ab 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
DOPNone listed
Apr 29, 2016Ab 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
DOPNone listed
Mar 25, 2016Ab 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
DOPNone listed
Sep 8, 2014Ab 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
DOPNone listed
Get alerts for these product codes