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Abbott Molecular

56 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
UroVysion Bladder Cancer Kit (P030052/S029)Abbott Molecular2025-01-29
RealTime CMV Assay (P160044/S005)Abbott Molecular2023-01-13
Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali (P160044/S004)Abbott Molecular2022-06-09
UroVysion Bladder Cancer Kit (P030052/S028)Abbott Molecular2022-03-18
Abbott RealTime CMV (P160044/S003)Abbott Molecular2021-03-05
Abbott RealTime HCV Genotype II (P120012/S019)Abbott Molecular2021-03-05
UroVysion Bladder Cancer Kit (P030052/S027)Abbott Molecular2020-12-11
UroVysion Bladder Cancer Kit (P030052/S026)Abbott Molecular2019-08-26
Abbott RealTime HCV GT II (P120012/S018)Abbott Molecular2019-05-15
Abbott RealTime CMV (P160044/S002)Abbott Molecular2019-05-15
UroVysion Bladder Cancer Kit (P030052/S025)Abbott Molecular2019-05-08
UroVysion Bladder Cancer Kit (P030052/S024)Abbott Molecular2018-08-29
UroVysion Bladder Cancer Kit (P030052/S023)Abbott Molecular2018-07-11
Abbott RealTime HCV Genotype II Assay (P120012/S017)Abbott Molecular2018-06-21
UroVysion Bladder Cancer Kit (P030052/S022)Abbott Molecular2018-03-12
UroVysion Bladder Cancer Kit (P030052/S021)Abbott Molecular2017-12-06
Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit (P120012/S016)Abbott Molecular2017-09-01
Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit. (P160044/S001)Abbott Molecular2017-09-01
ABBOTT REALTIME CMV (P160044)Abbott Molecular2017-05-18
Urovysion Bladder Cancer Kit (P030052/S020)Abbott Molecular2017-04-12
ABBOTT REALTIME HCV GENOTYPE II (P120012/S015)Abbott Molecular2016-12-23
URO VYSION BLADDER CANCER KIT (P030052/S019)Abbott Molecular2016-10-11
UROVYSION BLADDER CANCER KIT (P030052/S018)Abbott Molecular2016-09-29
ABBOTT REALTIME HCV GENOTYPE II ASSAY (P120012/S014)Abbott Molecular2016-06-30
ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S013)Abbott Molecular2016-06-10
ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S011)Abbott Molecular2016-04-20
ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S012)Abbott Molecular2016-04-12
ABBOTT REALTIME HCV GENOTYPE II (P120012/S010)Abbott Molecular2016-03-07
UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT (P030052/S017)Abbott Molecular2015-12-29
ABBOTT REALTIME HCV GENOTYPE II (P120012/S009)Abbott Molecular2015-10-09
REALTIME HCV GENOTYPE II (P120012/S007)Abbott Molecular2015-04-23
REALTIME HCV GENOTYPE II (P120012/S006)Abbott Molecular2014-12-10
ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S005)Abbott Molecular2014-11-20
ABBOTT REAL TIME HCV GENOTYPE II (P120012/S004)Abbott Molecular2014-09-25
UROVYSION BLADDER CANCER KIT (P030052/S016)Abbott Molecular2014-08-14
URO VYSION BLADDER CANCER KIT (P030052/S015)Abbott Molecular2014-07-16
UROVYSION BLADDER CANCER KIT (P030052/S012)Abbott Molecular2014-01-24
UROVYSION BLADDER CANCER KIT (P030052/S014)Abbott Molecular2013-12-20
URO VYSION BLADDER CANCER KIT (P030052/S013)Abbott Molecular2013-11-27
ABBOTT REALTIME HCV GENOTYPE II (P120012/S003)Abbott Molecular2013-08-20
ABBOTT REALTIME HCV GENOTYPE II (P120012/S002)Abbott Molecular2013-08-13
ABBOTT REAL TIME HCV GENOTYPE 11 (P120012/S001)Abbott Molecular2013-08-01
ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012)Abbott Molecular2013-06-20
UROVYSION BLADDER CANCER KIT (P030052/S011)Abbott Molecular2013-02-10
UROVYSION BLADDER CANCER KIT (P030052/S010)Abbott Molecular2012-11-13
UROVYSION BLADDER CANCER KIT ASSAY (P030052/S009)Abbott Molecular2012-08-10
URO VYSION BLADDER CANCER KIT ASSAY (P030052/S008)Abbott Molecular2011-07-20
UROVYSION BLADDER CANCER KIT ASSAY (P030052/S007)Abbott Molecular2011-06-01
UROVYSION BLADDER CANCER KIT (P030052/S006)Abbott Molecular2011-05-26
UROVYSION BLADDER CANCER KIT (P030052/S005)Abbott Molecular2011-04-08
UROVYSION BLADDER CANCER KIT (P030052/S004)Abbott Molecular2011-03-22
UROVYSION BLADDER CANCER KIT (P030052/S003)Abbott Molecular2009-02-25
UROVYSION BLADDER CANCER KIT (P030052/S002)Abbott Molecular2007-02-06
UROVYSION BLADDER CANCER KIT (P030052/S001)Abbott Molecular2006-05-10
UROVYSION BLADDER CANCER KIT (P030052)Abbott Molecular2005-01-24

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Every clearance here is in the API, with alerts when new ones post.