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Abbott Laboratories

549 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Alinity i Total PSA Assay (P910007/S051)Abbott Laboratories2020-08-07
ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato (P110029/S033)Abbott Laboratories2020-07-30
Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit (P110029/S030)Abbott Laboratories2020-06-05
Alinity i Anti-HBc IgM Reagent Kit (P060035/S028)Abbott Laboratories2020-06-05
Alinity i Free PSA assay (P980007/S041)Abbott Laboratories2020-06-05
Alinity i Anti-HBc Reagent Kit (P080023/S031)Abbott Laboratories2020-06-05
Alinity i AFP Reagent Kit (P120008/S013)Abbott Laboratories2020-06-05
Alinity i Anti-HBc lgM (P060035/S029)Abbott Laboratories2020-05-23
ARCHITECT CORE-M (P060035/S030)Abbott Laboratories2020-05-23
Alinity i Anti-HBc (P080023/S032)Abbott Laboratories2020-05-23
ARCHITECT HBsAg Qualitative/Confirmatory (P110029/S032)Abbott Laboratories2020-05-23
ARCHITECT CORE (P080023/S033)Abbott Laboratories2020-05-23
ARCHITECT Free PSA (P980007/S042)Abbott Laboratories2020-05-23
ARCHITECT Total PSA (P910007/S053)Abbott Laboratories2020-05-23
ARCHITECT AFP (P120008/S015)Abbott Laboratories2020-05-23
Alinity i AFP (P120008/S014)Abbott Laboratories2020-05-23
Alinity i HBsAg Qualitative II (P110029/S031)Abbott Laboratories2020-05-23
ARCHITECT Total PSA Reagent/Calibrator/Control Kit (P910007/S052)Abbott Laboratories2020-04-10
Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory (P110029/S029)Abbott Laboratories2020-01-07
Alinity i AFP Assay (P120008/S011)Abbott Laboratories2019-06-25
Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls (P060035/S026)Abbott Laboratories2019-06-20
Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls (P080023/S028)Abbott Laboratories2019-03-06
ARCHITECT AFP assay (P120008/S012)Abbott Laboratories2018-12-13
ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit (P060035/S027)Abbott Laboratories2018-11-20
ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S028)Abbott Laboratories2018-11-14
ARCHITECT CORE (LN 6L22) (P080023/S030)Abbott Laboratories2018-11-09
ARCHITECT CORE, LN 6L22 (P080023/S029)Abbott Laboratories2018-08-09
ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit (P110029/S027)Abbott Laboratories2018-07-18
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S026)Abbott Laboratories2017-09-27
Axsym Total PSA & Architect Total PSA (P910007/S050)Abbott Laboratories2017-03-28
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, (P110029/S024)Abbott Laboratories2016-11-10
ABBOTT ARCHITECT AFP ASSAY (P120008/S010)Abbott Laboratories2016-10-27
ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S023)Abbott Laboratories2016-04-06
ARCHITECT FREE PSA (LN 6C07) (P980007/S040)Abbott Laboratories2015-08-13
ARCHITECT TOTAL PSA (LN 6C06) (P910007/S049)Abbott Laboratories2015-08-13
ARCHITECT CORE-M (LN 6L23) (P060035/S025)Abbott Laboratories2015-08-13
ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) (P110029/S022)Abbott Laboratories2015-08-13
ARCHITECT AFP (LN 3P36) (P120008/S009)Abbott Laboratories2015-08-13
ARCHITECT CORE (LN 6L22) (P080023/S027)Abbott Laboratories2015-08-13
ARCHITECT AFP ASSAY (LN 3P36) (P120008/S008)Abbott Laboratories2015-07-13
ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS (P110029/S021)Abbott Laboratories2015-07-13
ARCHITECT FREE PSA (LN 6C07) (P980007/S039)Abbott Laboratories2015-03-26
ARCHITECT TOTAL PSA (LN 6C06) (P910007/S048)Abbott Laboratories2015-03-26
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS (P110029/S020)Abbott Laboratories2014-12-30
ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S019)Abbott Laboratories2014-12-17
ARCHITECT CORE (P080023/S026)Abbott Laboratories2014-12-11
ARCHITECT FREE PSA (P980007/S037)Abbott Laboratories2014-12-11
ARCHITECT HBSAG QUALITATIVE (P110029/S018)Abbott Laboratories2014-12-11
ARCHITECT TOTAL PSA (P910007/S046)Abbott Laboratories2014-12-11
ARCHITECT CORE-M (P060035/S024)Abbott Laboratories2014-12-11
ARCHITECT AFP (P120008/S007)Abbott Laboratories2014-12-11
ARCHITECT TOTAL PSA (LN 6CO6) (P910007/S047)Abbott Laboratories2014-12-08
ARCHITECT FREE PSA (LN 6C07) (P980007/S038)Abbott Laboratories2014-12-08
ARCHITECT CORE (LN 6L22) (P080023/S025)Abbott Laboratories2014-10-16
ARCHITECT CORE-M (LN 6L23) (P060035/S023)Abbott Laboratories2014-10-16
ARCHITECT TOTAL PSA (LN 6C06) (P910007/S045)Abbott Laboratories2014-06-18
ARCHITECT FREE PSA (LN 6C07) (P980007/S036)Abbott Laboratories2014-06-18
ARCHITECT TOTAL PSA (P910007/S044)Abbott Laboratories2014-05-28
ARCHITECT TOTAL PSA (P910007/S043)Abbott Laboratories2014-05-16
ARCHITECT FREE PSA (P980007/S034)Abbott Laboratories2014-05-16
ARCHITECT FREE PSA (P980007/S035)Abbott Laboratories2014-05-13
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S017)Abbott Laboratories2014-04-15
ARCHITECT AFP (P120008/S006)Abbott Laboratories2014-04-15
ARCHITECT FREE PSA (P980007/S033)Abbott Laboratories2014-02-03
ARCHITECT TOTAL PSA (P910007/S042)Abbott Laboratories2014-02-03
ARCHITECT AFP (P120008/S005)Abbott Laboratories2013-11-26
ARCHITECT CORE (P080023/S023)Abbott Laboratories2013-11-26
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S014)Abbott Laboratories2013-11-26
ARCHITECT FREE PSA (P980007/S031)Abbott Laboratories2013-11-26
ARCHITECT CORE (P080023/S024)Abbott Laboratories2013-11-26
ARCHITECT TOTAL PSA (P910007/S040)Abbott Laboratories2013-11-26
ARCHITECT TOTAL PSA (P910007/S041)Abbott Laboratories2013-11-26
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S016)Abbott Laboratories2013-11-26
ARCHITECT HBSAG QUAL/CONF (P110029/S015)Abbott Laboratories2013-11-26
ARCHITECT AFP (P120008/S004)Abbott Laboratories2013-11-26
ARCHITECT CORE-M (P060035/S021)Abbott Laboratories2013-11-26
ARCHITECT FREE PSA (P980007/S032)Abbott Laboratories2013-11-26
ARCHITECT CORE-M (P060035/S022)Abbott Laboratories2013-11-26
ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54 (P110029/S013)Abbott Laboratories2013-10-18
ARCHITECT CORE (P080023/S022)Abbott Laboratories2013-09-27
ARCHITECT AFP ASSAY (P120008/S002)Abbott Laboratories2013-08-27
ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT (P110029/S012)Abbott Laboratories2013-08-08
ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S027)Abbott Laboratories2013-07-18
ARCHITECT AFP,LN 3P36 (P120008/S003)Abbott Laboratories2013-06-12
ARCHITECT CORE-M (P060035/S020)Abbott Laboratories2013-03-13
ARCHITECT CORE-M (P060035/S019)Abbott Laboratories2013-03-13
ARCHITECT TOTAL PSA (P910007/S039)Abbott Laboratories2013-03-13
ARCHITECT CORE (P080023/S020)Abbott Laboratories2013-03-13
ARCHITECT FREE PSA (P980007/S030)Abbott Laboratories2013-03-13
ARCHITECT CORE (P080023/S021)Abbott Laboratories2013-03-13
ARCHITECT AFP (P120008/S001)Abbott Laboratories2013-03-13
ARCHITECT HBSAG/CONFIRMATORY (P060007/S026)Abbott Laboratories2013-03-13
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S011)Abbott Laboratories2013-03-13
ARCHITECT I1000 SYSTEM (P110029/S001)Abbott Laboratories2013-01-10
ARCHITECT CORE-M (P060035/S018)Abbott Laboratories2012-12-14
ARCHITECT HBSAG/CONFIRMATORY (P060007/S025)Abbott Laboratories2012-12-14
ARCHITECT CORE (P080023/S019)Abbott Laboratories2012-12-14
ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY (P110029/S010)Abbott Laboratories2012-12-14
ARCHITECT FREE PSA AND AXSYM FREE PSA (P980007/S027)Abbott Laboratories2012-12-11
ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA (P910007/S036)Abbott Laboratories2012-12-11
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Every clearance here is in the API, with alerts when new ones post.