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Abbott Laboratories

549 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/ Confirmatory (P110029/S051)Abbott Laboratories2024-09-30
ARCHITECT HBsAg Qualitative Confirmatory/ Alinity i HBsAg Qualitative II Confirmatory (P110029/S050)Abbott Laboratories2024-05-23
ARCHITECT CORE/ Alinity i Anti-HBc (P080023/S045)Abbott Laboratories2024-03-22
ARCHITECT AFP / Alinity i AFP (P120008/S029)Abbott Laboratories2024-03-22
ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con (P210003/S011)Abbott Laboratories2024-03-22
Architect AFP and Alinity i AFP (P120008/S028)Abbott Laboratories2024-01-30
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S042)Abbott Laboratories2023-12-14
ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg (P210003/S010)Abbott Laboratories2023-12-14
ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qualitative II (P110029/S049)Abbott Laboratories2023-12-14
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S044)Abbott Laboratories2023-12-14
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S054)Abbott Laboratories2023-12-14
ARCHITECT AFP / Alinity i AFP (P120008/S027)Abbott Laboratories2023-12-14
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S065)Abbott Laboratories2023-12-14
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S009)Abbott Laboratories2023-12-07
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory (P110029/S048)Abbott Laboratories2023-12-07
Alinity i Free PSA Reagent Kit (P980007/S053)Abbott Laboratories2023-11-08
Alinity i Total PSA Reagent Kit (P910007/S064)Abbott Laboratories2023-11-08
Alinity i AFP Reagent Kit (P120008/S026)Abbott Laboratories2023-11-08
Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests) (P060035/S041)Abbott Laboratories2023-11-06
Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al (P110029/S047)Abbott Laboratories2023-11-06
Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S043)Abbott Laboratories2023-11-06
Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S042)Abbott Laboratories2023-11-03
Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests) (P060035/S040)Abbott Laboratories2023-11-03
Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin (P110029/S046)Abbott Laboratories2023-11-03
ARCHITECT Free PSA, Alinity i Free PSA (P980007/S049)Abbott Laboratories2023-10-11
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S038)Abbott Laboratories2023-10-11
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S042)Abbott Laboratories2023-10-11
ARCHITECT Total PSA, Alinity i Total PSA (P910007/S060)Abbott Laboratories2023-10-11
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S040)Abbott Laboratories2023-10-11
ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S007)Abbott Laboratories2023-10-11
ARCHITECT AFP, Alinity i AFP (P120008/S022)Abbott Laboratories2023-10-11
Alinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay (P210003/S006)Abbott Laboratories2023-09-28
Alinity i AFP (P120008/S025)Abbott Laboratories2023-09-25
Alinity i Total PSA (P910007/S063)Abbott Laboratories2023-09-25
Alinity i Free PSA (P980007/S052)Abbott Laboratories2023-09-25
ARCHITECT AFP / Alinity i AFP (P120008/S024)Abbott Laboratories2023-07-10
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S051)Abbott Laboratories2023-07-10
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S041)Abbott Laboratories2023-07-10
ARCHITECT HBsAg Qualitative/ Qualitative Confirmatory / Alinity i HBsAg Qualitative II/ Qualitative II Confirmatory (P110029/S045)Abbott Laboratories2023-07-10
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S039)Abbott Laboratories2023-07-10
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S008)Abbott Laboratories2023-07-10
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S062)Abbott Laboratories2023-07-10
ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory (P110029/S043)Abbott Laboratories2023-06-23
ARCHITECT AFP, Alinity i AFP (P120008/S023)Abbott Laboratories2023-06-22
ARCHITECT Free PSA, Alinity i Free PSA (P980007/S050)Abbott Laboratories2023-06-22
ARCHITECT Total PSA, Alinity i Total PSA (P910007/S061)Abbott Laboratories2023-06-22
ARCHITECT HBsAg Qualitative, HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S044)Abbott Laboratories2023-06-22
ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory Assay (P210003/S004)Abbott Laboratories2023-05-08
ARCHITECT AFP / Alinity i AFP (P120008/S021)Abbott Laboratories2023-01-30
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S059)Abbott Laboratories2023-01-30
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S037)Abbott Laboratories2023-01-30
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S039)Abbott Laboratories2023-01-30
ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S005)Abbott Laboratories2023-01-30
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S048)Abbott Laboratories2023-01-30
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S041)Abbott Laboratories2023-01-30
ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory (P110029/S040)Abbott Laboratories2022-12-07
ARCHITECT HBsAg Next Qualitative/Next Confirmatory (P210003/S003)Abbott Laboratories2022-12-07
Alinity i Anti-HBc (List Number 07P84) (P080023/S038)Abbott Laboratories2022-10-25
Alinity i Anti-HBc IgM (List Number 07P86) (P060035/S036)Abbott Laboratories2022-10-25
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S035)Abbott Laboratories2022-10-12
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S039)Abbott Laboratories2022-10-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S037)Abbott Laboratories2022-10-12
ARCHITECT AFP / Alinity i AFP (P120008/S020)Abbott Laboratories2022-10-12
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S002)Abbott Laboratories2022-10-12
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S058)Abbott Laboratories2022-10-12
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S047)Abbott Laboratories2022-10-12
ARCHITECT HBsAg Next Qualitative/ Next Confirmatory (P210003/S001)Abbott Laboratories2022-09-30
ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory (P110029/S038)Abbott Laboratories2022-09-30
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S037)Abbott Laboratories2022-08-10
ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit (P210003)Abbott Laboratories2022-08-10
ARCHITECT AFP / Alinity i AFP (P120008/S019)Abbott Laboratories2021-12-17
ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory (P110029/S036)Abbott Laboratories2021-12-15
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S036)Abbott Laboratories2021-12-15
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S046)Abbott Laboratories2021-12-15
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S057)Abbott Laboratories2021-12-15
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S034)Abbott Laboratories2021-12-15
ARCHITECT Free PSA (LN 6C07) (P980007/S045)Abbott Laboratories2021-12-06
ARCHITECT CORE (LN 6L22) (P080023/S035)Abbott Laboratories2021-12-06
ARCHITECT CORE-M (LN 6L23) (P060035/S033)Abbott Laboratories2021-12-06
ARCHITECT AFP (LN 3P36) (P120008/S018)Abbott Laboratories2021-12-06
ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S035)Abbott Laboratories2021-12-06
ARCHITECT Total PSA (LN 6C06) (P910007/S056)Abbott Laboratories2021-12-06
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S031)Abbott Laboratories2021-05-14
ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit (P980007/S044)Abbott Laboratories2021-04-22
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit (P080023/S034)Abbott Laboratories2021-04-22
ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit (P910007/S055)Abbott Laboratories2021-04-22
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S032)Abbott Laboratories2021-04-22
ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re (P110029/S034)Abbott Laboratories2021-04-22
ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit (P120008/S017)Abbott Laboratories2021-04-22
ARCHITECT Free PSA and Alinity i Free PSA (P980007/S043)Abbott Laboratories2020-11-05
ARCHITECT AFP and Alinity i AFP (P120008/S016)Abbott Laboratories2020-11-05
ARCHITECT Total PSA and Alinity i Total PSA (P910007/S054)Abbott Laboratories2020-11-05
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Every clearance here is in the API, with alerts when new ones post.