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Abbott Laboratories

FDA 510(k) & PMA Approved Devices — 876 products

Total Devices876
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262156 Anti-HCV NextMZO2026-09-23 View
510(k) K252424 Anti-HCV NextMZO2026-04-28 View
510(k) K243500 ARCHITECT iGentamicinLCD2025-07-09 View
510(k) K243168 Alinity i Rubella IgGLFX2025-06-20 View
510(k) K243283 Alinity h-series SystemGKZ2025-02-20 View
510(k) K233932 Alinity i Toxo IgMLGD2024-08-30 View
510(k) K232669 TBIQAT2023-09-29 View
510(k) K222850 HAVAb IgG IILOL2023-08-10 View
510(k) K220031 Alinity h-series SystemGKZ2023-08-04 View
510(k) K220282 i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS2023-07-14 View
510(k) K230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA2023-06-05 View
510(k) K230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesDHA2023-05-19 View
510(k) K223602 Traumatic brain injury (TBI) testQAT2023-03-02 View
510(k) K220949 Architect CMV IgGLFZ2022-10-27 View
510(k) K210596 ARCHITECT Toxo IgGLGD2022-05-19 View
510(k) K213486 GLP systems TrackJGS2022-03-10 View
510(k) K201778 i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT2021-01-08 View
510(k) K190294 CELL-DYN Emerald 22 AL SystemGKZ2019-03-15 View
510(k) K181748 MagnesiumJGJ2018-09-12 View
510(k) K173294 MagnesiumJGJ2018-05-18 View
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