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Abbott Laboratories

549 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ARCHITECT CORE-M (P060035/S006)Abbott Laboratories2011-03-22
ARCHITECT HBSAG/CONFIRMATORY (P060007/S007)Abbott Laboratories2011-03-22
ABBOTT ARCHITECT TOTAL PSA (P910007/S019)Abbott Laboratories2011-03-22
ARCHITECT CORE (P080023/S006)Abbott Laboratories2011-03-22
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S033)Abbott Laboratories2011-03-10
ARCHITECT TOTAL PSA (P910007/S027)Abbott Laboratories2011-03-07
ARCHITECT FREE PSA (P980007/S018)Abbott Laboratories2011-03-07
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S022)Abbott Laboratories2011-01-14
ARCHITECT HBSAG/CONFIRMATORY (P060007/S006)Abbott Laboratories2011-01-14
ARCHITECT CORE (P080023/S004)Abbott Laboratories2011-01-14
ARCHITECT CORE-M (P060035/S004)Abbott Laboratories2011-01-14
ARCHITECT FREE PSA (P980007/S015)Abbott Laboratories2011-01-13
ARCHITECT TOTAL PSA (P910007/S024)Abbott Laboratories2011-01-13
AXSYM ANTI-HCV (P970027/S012)Abbott Laboratories2011-01-05
ARCHITECT CORE-M (P060035/S002)Abbott Laboratories2011-01-04
ARCHITECH CORE (P080023/S002)Abbott Laboratories2011-01-04
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S028)Abbott Laboratories2010-11-23
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S029)Abbott Laboratories2010-11-23
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S031)Abbott Laboratories2010-11-23
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S027)Abbott Laboratories2010-11-23
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S026)Abbott Laboratories2010-11-18
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S030)Abbott Laboratories2010-11-18
AXSYM AFP (LN 7A48) (P820060/S025)Abbott Laboratories2010-10-20
AXSYM FREE PSA (LN 3C20) (P980007/S012)Abbott Laboratories2010-10-20
AXSYM TOTAL PSA (LN 3C19) (P910007/S020)Abbott Laboratories2010-10-20
AXSYM ANTI-HCV (LN 5C36) (P970027/S010)Abbott Laboratories2010-10-19
AXSYM ANTI-HCV (P970027/S009)Abbott Laboratories2010-09-20
ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S018)Abbott Laboratories2010-08-31
ARCHITECT FREE PSA ASSAY (P980007/S010)Abbott Laboratories2010-08-31
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S024)Abbott Laboratories2010-07-09
ABBOTT AXSYM ANTI-HCV (P970027/S008)Abbott Laboratories2010-05-13
ABBOTT AFP-EIA (P820060/S024)Abbott Laboratories2010-02-26
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S017)Abbott Laboratories2010-01-19
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S021)Abbott Laboratories2010-01-11
ABBOTT ARCHITECT CORE ASSAY (P080023/S001)Abbott Laboratories2009-12-10
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S020)Abbott Laboratories2009-11-20
FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM (P050020/S008)Abbott Laboratories2009-10-29
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S010)Abbott Laboratories2009-09-25
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S019)Abbott Laboratories2009-09-21
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S018)Abbott Laboratories2009-08-21
ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM (P060007/S002)Abbott Laboratories2009-07-13
ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV) (P970027/S007)Abbott Laboratories2009-07-08
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S015)Abbott Laboratories2009-06-24
ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035/S001)Abbott Laboratories2009-06-23
ABBOTT ARCHITECT HBSAG (P060007/S003)Abbott Laboratories2009-06-05
ARCHITECT TOTAL PSA ASSAY (P910007/S017)Abbott Laboratories2009-05-29
MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM (P980007/S009)Abbott Laboratories2009-05-28
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S012)Abbott Laboratories2009-05-08
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S011)Abbott Laboratories2009-04-13
ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS (P080023)Abbott Laboratories2009-04-10
FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM (P050020/S013)Abbott Laboratories2009-04-09
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S009)Abbott Laboratories2009-03-06
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S004)Abbott Laboratories2008-10-08
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S007)Abbott Laboratories2008-08-25
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S006)Abbott Laboratories2008-08-06
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S005)Abbott Laboratories2008-06-02
FREESTYLE NAVIGATOR (P050020/S003)Abbott Laboratories2008-05-21
ABBOTT ARCHITECT AFP (P820060/S023)Abbott Laboratories2008-05-21
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S002)Abbott Laboratories2008-05-15
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S001)Abbott Laboratories2008-04-02
ABBOTT AXSYM AFP (P820060/S022)Abbott Laboratories2008-03-26
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR (P050020)Abbott Laboratories2008-03-12
ABBOTT AXSYM ANTI-HCV (P970027/S006)Abbott Laboratories2008-02-22
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035)Abbott Laboratories2007-11-06
AXSYM ANTIBODY TO HCV (P970027/S005)Abbott Laboratories2007-02-05
IMX PSAS (P910007/S016)Abbott Laboratories2007-02-01
ABBOTT IMX FREE PSA (P980007/S008)Abbott Laboratories2007-02-01
ABBOTT AFP-EIA DIAGNOSTIC KIT (P820060/S021)Abbott Laboratories2007-02-01
ARCHITECT HBSAG AND HBSAG CONFIRMATORY (P060007/S001)Abbott Laboratories2006-10-18
ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT (P060007)Abbott Laboratories2006-09-07
ABBOTT IMX HAVAB-M LIST 2263 (P790019/S020)Abbott Laboratories2005-10-06
ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA (P910007/S015)Abbott Laboratories2005-09-13
ABBOTT IMX TOTAL PSA (P910007/S013)Abbott Laboratories2005-06-13
ABBOTT HAVAB -M EIA (P790019/S019)Abbott Laboratories2005-05-25
ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36) (P970027/S004)Abbott Laboratories2005-01-31
ABBOTT AXSYM ANTI-HCV (P970027/S003)Abbott Laboratories2004-12-14
AXSYM ANTI-HCV (P970027/S002)Abbott Laboratories2004-12-03
ABBOTT AXSYM TOTAL PSA ASSAY (P910007/S011)Abbott Laboratories2004-09-27
ABBOTT ARCHITECT FREE PSA (P980007/S006)Abbott Laboratories2004-09-10
ABBOTT AXSYM FREE PSA ASSAY (P980007/S005)Abbott Laboratories2004-09-10
ABBOTT ARCHITECT TOTAL PSA (P910007/S012)Abbott Laboratories2004-09-10
AXSYM HAVAB 2.0 (P780012/S014)Abbott Laboratories2004-07-30
ABBOTT AXSYM ANTI-HCV (P970027/S001)Abbott Laboratories2004-06-30
DEVICE: ABBOTT AXSYM HAVAB-M 2.0 (P790019/S018)Abbott Laboratories2004-06-16
ABBOTT ARCHITECT FREE PSA (P980007/S004)Abbott Laboratories2004-05-07
ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S010)Abbott Laboratories2004-04-28
ABBOTT AXSYM FREE PSA (P980007/S001)Abbott Laboratories2004-04-15
ABBOTT AXSYM/TOTAL PSA (P910007/S006)Abbott Laboratories2004-03-03
ABBOTT IMX FREE PSA (P980007/S003)Abbott Laboratories2004-02-05
AXSYM FREE PSA (P980007)Abbott Laboratories2004-02-05
ABBOTT ARCHITECT FREE PSA (P980007/S002)Abbott Laboratories2004-02-05
ABBOTT AXSYM ANTIBODY TO HCV (P970027)Abbott Laboratories2004-02-05
ABBOTT ARCHITECT TOTAL PSA (P910007/S007)Abbott Laboratories2004-02-02
ABBOTT ARCHITECHT AFP (P820060/S013)Abbott Laboratories2004-02-02
ABBOTT AXSYM AFP (P820060/S019)Abbott Laboratories2004-02-02
ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER (P820060/S016)Abbott Laboratories2004-02-02
ABBOTT AXSYM HAVAB 2.0 (P780012/S009)Abbott Laboratories2004-02-02
ABBOTT IMX TOTAL PSA (P910007/S009)Abbott Laboratories2004-02-02
ABBOTT AXSYM TOTAL PSA (P910007/S005)Abbott Laboratories2004-02-02
ABBOTT AXSYM HAVAB-M 2.0 (P790019/S011)Abbott Laboratories2004-02-02
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