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Abbott Molecular, Inc.

188 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Vysis ALK Break Apart Fish Probe Kit (P110012/S014)Abbott Molecular, Inc.2017-12-06
Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit (P080026/S021)Abbott Molecular, Inc.2017-09-01
Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit (P100017/S020)Abbott Molecular, Inc.2017-09-01
Abbott RealTime IDH2 (P170005)Abbott Molecular, Inc.2017-08-01
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S013)Abbott Molecular, Inc.2017-04-12
ABBOTT REALTIME HCV (P100017/S019)Abbott Molecular, Inc.2016-12-23
ABBOTT REALTIME HBV ASSAY (P080026/S020)Abbott Molecular, Inc.2016-12-23
ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA (P080026/S019)Abbott Molecular, Inc.2016-12-13
ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA. (P080026/S018)Abbott Molecular, Inc.2016-11-22
VYSIS ALK BREAK APART FISH PROBE KIT. (P110012/S012)Abbott Molecular, Inc.2016-10-11
PATHVYSION HER-2 DNA PROBE KIT (P980024/S015)Abbott Molecular, Inc.2016-09-29
Vysis ALK Break Apart FISH Probe Kit (P110012/S011)Abbott Molecular, Inc.2016-09-29
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S010)Abbott Molecular, Inc.2016-07-13
PATH VYSION HER-2 DNA PROBE KIT (P980024/S014)Abbott Molecular, Inc.2016-07-13
ABBOTT REALTIME HCV ASSAY (P100017/S018)Abbott Molecular, Inc.2016-06-30
ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI (P100017/S017)Abbott Molecular, Inc.2016-06-10
ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S015)Abbott Molecular, Inc.2016-04-20
ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S016)Abbott Molecular, Inc.2016-04-12
ABBOTT REALTIME HBV ASSAY (P080026/S017)Abbott Molecular, Inc.2016-04-12
VYSIS CLL FISH PROBE KIT (P150041)Abbott Molecular, Inc.2016-04-11
ABBOTT REALTIME HCV (P100017/S014)Abbott Molecular, Inc.2015-10-09
ABBOTT REALTIME HBV (P080026/S016)Abbott Molecular, Inc.2015-10-09
VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT (P110012/S009)Abbott Molecular, Inc.2015-07-02
ABBOTT REALTIME HBV ASSAY (P080026/S014)Abbott Molecular, Inc.2015-04-23
ABBOTT REALTIME HCV ASSAY (P100017/S012)Abbott Molecular, Inc.2015-04-23
ABBOTT REALTIME HCV ASSAY (P100017/S011)Abbott Molecular, Inc.2014-12-10
ABBOTT REALTIME HVB ASSAY (P080026/S013)Abbott Molecular, Inc.2014-12-10
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S007)Abbott Molecular, Inc.2014-12-10
ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P100017/S010)Abbott Molecular, Inc.2014-11-20
ABBOTT REALTIME HBV ASSAY (P080026/S012)Abbott Molecular, Inc.2014-11-20
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S008)Abbott Molecular, Inc.2014-08-14
PATH VYSION HER-2 DNA PROBE KIT (P980024/S013)Abbott Molecular, Inc.2014-07-16
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S006)Abbott Molecular, Inc.2014-07-16
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S004)Abbott Molecular, Inc.2014-01-24
PATHVYSION HER-2 DNA PROBE KIT (P980024/S012)Abbott Molecular, Inc.2013-12-20
ABBOTT REALTIME HBV ASSAY (P080026/S011)Abbott Molecular, Inc.2013-12-11
ABBOTT REALTIME HCV ASSAY (P100017/S009)Abbott Molecular, Inc.2013-12-11
THE PATH VYSION HER-2 DNA PRODE KIT (P980024/S011)Abbott Molecular, Inc.2013-11-27
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S005)Abbott Molecular, Inc.2013-11-27
ABBOTT REAL TIME HBV CALIBRATOR KIT (P100017/S008)Abbott Molecular, Inc.2013-11-19
ABBOTT REAL TIME HBV CONTROL KIT (P080026/S010)Abbott Molecular, Inc.2013-11-19
HBV ASSAY (P080026/S006)Abbott Molecular, Inc.2013-10-15
ABBOTT REAL TIME HCV (P100017/S005)Abbott Molecular, Inc.2013-09-25
ABBOTT REAL TIME HBV (P080026/S008)Abbott Molecular, Inc.2013-09-10
ABBOTT REALTIME HBV (P080026/S009)Abbott Molecular, Inc.2013-08-20
ABBOTT REALTIME HCV (P100017/S007)Abbott Molecular, Inc.2013-08-20
ABBOTT REALTIME HBV (P080026/S007)Abbott Molecular, Inc.2013-05-28
ABBOTT REALTIME HCV (P100017/S006)Abbott Molecular, Inc.2013-05-28
VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES (P110012/S003)Abbott Molecular, Inc.2013-04-17
ABBOTT REALTIME HCV (P100017/S004)Abbott Molecular, Inc.2013-03-01
PATHVYSION HER-2 DNA PROBE KIT (P980024/S010)Abbott Molecular, Inc.2013-02-10
ABBOTT REALTIME HBV (P080026/S005)Abbott Molecular, Inc.2013-02-07
PATHVYSION HER-2 DNA PROBE KIT (P980024/S009)Abbott Molecular, Inc.2012-12-26
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S002)Abbott Molecular, Inc.2012-12-26
PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S007)Abbott Molecular, Inc.2012-12-20
ABBOTT REALTIME HCV (P100017/S003)Abbott Molecular, Inc.2012-11-01
ABBOTT REALTIME HBV (P080026/S004)Abbott Molecular, Inc.2012-11-01
ABBOTT REALTIME HCV (P100017/S002)Abbott Molecular, Inc.2012-09-27
ABBOTT REALTIME HBV ASSAY (P080026/S003)Abbott Molecular, Inc.2012-09-26
PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S008)Abbott Molecular, Inc.2012-07-17
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S001)Abbott Molecular, Inc.2012-06-07
PATHVYSION HER-2 DNA PROBE KIT (P980024/S006)Abbott Molecular, Inc.2012-02-27
ABBOTT REALTIME HBV ASSAY (P080026/S002)Abbott Molecular, Inc.2011-11-30
ABBOTT REALTIME HCV ASSAY (P100017/S001)Abbott Molecular, Inc.2011-11-30
VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK (P110012)Abbott Molecular, Inc.2011-08-26
ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017)Abbott Molecular, Inc.2011-05-17
PATHVYSION HER-2 DNA PROBE KIT (P980024/S005)Abbott Molecular, Inc.2011-04-18
PATHVYSION HER-2 DNA PROBE KIT (P980024/S004)Abbott Molecular, Inc.2011-01-10
ABBOTT REALTIME HBV ASSAY (P080026)Abbott Molecular, Inc.2010-08-13
PATHVYSION HER-2 DNA PROBE KIT (P980024/S003)Abbott Molecular, Inc.2009-02-10
VYSIS PATH VYSION HER-2 DNA PROBE KIT (P980024/S002)Abbott Molecular, Inc.2006-05-10
PATHVYSION HER-2 DNA PROBE KIT (P980024/S001)Abbott Molecular, Inc.2001-12-31
PATHVYSION HER-2 DNA PROBE KIT (P980024)Abbott Molecular, Inc.1998-12-11
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