Abbott Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Abbott Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P050051S045 ABBOTT LABORATORIES INC	ARCHITECT AUSAB / Alinity i Anti-HBs	2021-12-15
PMA P050042S047 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV / Alinity i Anti-HCV	2021-12-15
PMA P050051S044 ABBOTT LABORATORIES INC	ARCHITECT AUSAB (LN 1L82)	2021-12-06
PMA P050042S046 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV (LN 1L79)	2021-12-06
PMA P050051S042 ABBOTT LABORATORIES INC	Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al	2021-09-09
PMA P050051S041 ABBOTT LABORATORIES INC	ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit	2021-04-22
PMA P050042S045 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit	2021-04-22
PMA P050051S040 ABBOTT LABORATORIES INC	ARCHITECT AUSAB and Alinity i Anti-HBs	2020-11-05
PMA P050042S044 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV, Alinity i Anti-HCV	2020-08-28
PMA P050051S039 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2020-05-23
PMA P050051S038 ABBOTT LABORATORIES INC	Alinity i Anti-HBs	2020-05-23
PMA P050042S043 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV and Alinity i Anti-HCV	2020-04-29
PMA P050051S036 ABBOTT LABORATORIES INC	ARCHITECT AUSAB, LN 1L82	2019-12-03
PMA P050042S039 ABBOTT LABORATORIES INC	Architect Anti-HCV and Alinity i Anti-HCV	2019-08-13
PMA P050051S035 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2019-07-03
PMA P050051S033 ABBOTT LABORATORIES INC	Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls	2019-03-06
PMA P050042S038 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV Reagent Kit	2019-01-24
PMA P050051S034 ABBOTT LABORATORIES INC	ARCHITECT AUSAB (LN 1L82)	2018-11-14
PMA P050042S037 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV (LN 1L79)	2018-11-09
PMA P050042S036 ABBOTT LABORATORIES INC	Architect Anti-HCV Regent Kit (100, 500 Test)	2018-11-07
PMA P050042S035 ABBOTT LABORATORIES INC	ARCHITECT Anti-HCV	2018-10-19
PMA P050051S032 ABBOTT LABORATORIES INC	ABBOTT ARCHITECT AUSAB	2016-12-09
PMA P050051S031 ABBOTT LABORATORIES INC	ABBOTT ARCHITECT AUSAB	2016-07-13
PMA P050042S033 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL	2016-03-24
PMA P050051S030 ABBOTT LABORATORIES INC	ARCHITECT AUSAB (LN 1L82)	2015-08-13
PMA P050042S032 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV (LN 1L79)	2015-08-13
PMA P050051S029 ABBOTT LABORATORIES INC	ARCHITECT AUSAB PMA ASSAY	2014-12-30
PMA P050051S028 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2014-12-11
PMA P050042S031 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2014-12-11
PMA P050051S027 ABBOTT LABORATORIES INC	ARCHITECT AUSAB (LN 1L82)	2014-10-29
PMA P050042S030 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV (LN IL79)	2014-10-16
PMA P050042S029 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2014-04-28
PMA P050051S026 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2014-04-15
PMA P050051S025 ABBOTT LABORATORIES INC	ARCHITECT AUSAB ASSAY	2014-01-09
PMA P050051S024 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2013-11-26
PMA P050051S023 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2013-11-26
PMA P050042S028 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2013-11-26
PMA P050042S027 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2013-11-26
PMA P050042S026 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV ASSAY, LN IL79	2013-11-15
PMA P050051S022 ABBOTT LABORATORIES INC	ARCHITECT AUSAB LN 1L82	2013-10-18
PMA P050042S025 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV LN 1L79	2013-08-30
PMA P050051S021 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2013-07-18
PMA P050042S024 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2013-05-22
PMA P050051S020 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2013-03-13
PMA P050042S023 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2013-03-13
PMA P050042S022 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2013-03-13
PMA P050051S019 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2012-12-14
PMA P050042S021 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2012-12-14
PMA P050051S018 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2012-12-10
PMA P050042S020 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2012-12-10
PMA P060012S010 ABBOTT LABORATORIES INC	AXSYM CORE 2.0	2012-12-05
PMA P060009S007 ABBOTT LABORATORIES INC	AXSYM CORE-M 2.0	2012-12-05
PMA P060003S012 ABBOTT LABORATORIES INC	AXSYM AUSAB	2012-12-05
PMA P050051S017 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2012-12-05
PMA P050049S011 ABBOTT LABORATORIES INC	AXSYM HBSAG/HBSAG CONFIRMATORY	2012-12-05
PMA P050042S019 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2012-12-05
PMA P050051S016 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2012-11-27
PMA P050051S015 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2012-08-30
PMA P050042S018 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2012-08-30
PMA P050042S017 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2012-07-31
PMA P050042S016 ABBOTT LABORATORIES INC	ARCHTECT ANTI-HCV	2012-04-13
PMA P050049S010 ABBOTT LABORATORIES INC	AXSYM HBSAG	2012-03-01
PMA P060012S009 ABBOTT LABORATORIES INC	AXSYM CORE 2.0 (LN 8B88)	2011-12-22
PMA P060009S006 ABBOTT LABORATORIES INC	AXSYM CORE-M 2.0 (LN 3B89)	2011-12-22
PMA P060003S011 ABBOTT LABORATORIES INC	AXSYM AUSAB (LN 3C74)	2011-12-22
PMA P050049S009 ABBOTT LABORATORIES INC	AXSYM HBSAG/CONFIRMATORY (LN 9B01)	2011-12-22
PMA P050051S014 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-12-21
PMA P050042S015 ABBOTT LABORATORIES INC	ACHITECT ANTI-HCV	2011-12-21
PMA P050042S014 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2011-12-01
PMA P050049S008 ABBOTT LABORATORIES INC	ABBOTT AXSYM HBSAG	2011-11-14
PMA P060012S008 ABBOTT LABORATORIES INC	AXSYM CORE	2011-10-07
PMA P060003S010 ABBOTT LABORATORIES INC	ABBOTT AXSYM AUSAB	2011-10-03
PMA P050051S006 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-07-20
PMA P050042S007 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2011-07-20
PMA P050049S007 ABBOTT LABORATORIES INC	ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY	2011-07-01
PMA P050051S013 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-06-24
PMA P050042S013 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2011-06-24
PMA P060003S005 ABBOTT LABORATORIES INC	ABBOTT AXSYM AUSAB	2011-06-09
PMA P050051S012 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-06-01
PMA P050042S012 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2011-06-01
PMA P060012S005 ABBOTT LABORATORIES INC	AXSYM CORE	2011-05-20
PMA P060009S003 ABBOTT LABORATORIES INC	AXSYM CORE-M	2011-05-20
PMA P060003S007 ABBOTT LABORATORIES INC	AXSYM AUSAB	2011-05-20
PMA P050049S005 ABBOTT LABORATORIES INC	AXSYM HBSAG/CONFIRMATORY	2011-05-20
PMA P060003S009 ABBOTT LABORATORIES INC	ABBOTT AXSYM AUSAB	2011-05-13
PMA P050051S011 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-05-13
PMA P050042S011 ABBOTT LABORATORIES INC	ARCHITECT ANTI-HCV	2011-05-13
PMA P060012S007 ABBOTT LABORATORIES INC	AXSYM CORE 2.0	2011-04-21
PMA P060012S006 ABBOTT LABORATORIES INC	AXSYM CORE 2.0	2011-04-15
PMA P060009S004 ABBOTT LABORATORIES INC	AXSYM CORE-M 2.0	2011-04-15
PMA P060003S008 ABBOTT LABORATORIES INC	AXSYM AUSAB	2011-04-15
PMA P050049S006 ABBOTT LABORATORIES INC	AXSYM HBSAG/CONFIRMATORY	2011-04-15
PMA P060009S005 ABBOTT LABORATORIES INC	AXSYM CORE-M 2.0	2011-04-04
PMA P050051S007 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-04-04
PMA P050051S005 ABBOTT LABORATORIES INC	ARCHITECT AUSAB	2011-04-04
PMA P050051S010 ABBOTT LABORATORIES INC	ABBOTT ARCHITECT AUSAB	2011-03-23
PMN K090358 ABBOTT LABORATORIES INC	ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35	2009-08-06
PMN K061193 ABBOTT LABORATORIES INC	CREATININE	2006-06-23
PMN K051213 ABBOTT LABORATORIES INC	PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS	2005-05-27
PMN K040954 ABBOTT LABORATORIES INC	FOX PLUS PTA CATHETER	2004-05-11
PMN K040761 ABBOTT LABORATORIES INC	AXSYM CYCLOSPORINE	2004-04-30
PMN K023062 ABBOTT LABORATORIES INC	GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT	2002-09-30

Similar & Related FDA Registered Companies

• ABBOTT LABORATORIES (PERCLOSE, INC.)
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS049 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS048 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS046 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	1BUE5	ABBOTT LABORATORIES INC
NCAGE Code	1M8F7	ABBOTT LABORATORIES INC
NCAGE Code	1TSB3	ABBOTT LABORATORIES INC
NCAGE Code	5M011	ABBOTT LABORATORIES INC
CAGE Code	1BUE5	ABBOTT LABORATORIES INC
CAGE Code	1M8F7	ABBOTT LABORATORIES INC
CAGE Code	1RGF3	ABBOTT LABORATORIES INC. PHARMACEUTICAL PRODUCTS DIVISION
CAGE Code	1S7F5	ABBOTT LABORATORIES INC. PHARMACEUTICAL PRODUCTS DIVISION
CAGE Code	1TSB3	ABBOTT LABORATORIES INC
CAGE Code	23281	ABBOTT LABORATORIES, INC. ROSS PRODUCTS DIVISION ROSS PRODUCTS
CAGE Code	60060	ABBOTT LABORATORIES INC. HOSPITAL PRODUCTS DIVISION
CAGE Code	6AWN5	ABBOTT LABORATORIES INC
CAGE Code	5M011	ABBOTT LABORATORIES INC
S.A.M. Registration	6AWN5 [967474896]	ABBOTT LABORATORIES INC