Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories

882 submissions · 867 cleared · Since 1976
882
Total
867
Cleared
0
Denied

Abbott Laboratories — FDA 510(k) Submissions

Abbott Laboratories has submitted 882 FDA 510(k) premarket notifications since 1976, of which 867 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Infusion, Set, Administration, Intravascular, Counter, Differential Cell, Tubes, Gastrointestinal (and Accessories), Diazo Colorimetry, Bilirubin . Use the specialty filter in the sidebar to narrow results.

882 devices
1–25 of 882
ARCHITECT iGentamicin
K243500 · LCD Enzyme Immunoassay,... · Toxicology
Jul 2025 239d
Alinity i Rubella IgG
K243168 · LFX Enzyme Linked... · Microbiology
Jun 2025 263d
Alinity h-series System
K243283 · GKZ Counter, Differential Cell · Hematology
Feb 2025 126d
Alinity i Toxo IgM
K233932 · LGD Enzyme Linked... · Microbiology
Aug 2024 260d
TBI
K232669 · QAT Brain Trauma Assessment Test · Immunology
Sep 2023 28d
HAVAb IgG II
K222850 · LOL Hepatitis A Test... · Microbiology
Aug 2023 323d
Alinity h-series System
K220031 · GKZ Counter, Differential Cell · Hematology
Aug 2023 576d
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · GJS Test, Time, Prothrombin · Hematology
Jul 2023 528d
Alinity i Total ?-hCG Reagent Kit, GLP systems Track
K230937 · DHA System, Test, Human... · Chemistry
Jun 2023 63d
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
K230790 · DHA System, Test, Human... · Chemistry
May 2023 58d
Traumatic brain injury (TBI) test
K223602 · QAT Brain Trauma Assessment Test · Immunology
Mar 2023 90d
Architect CMV IgG
K220949 · LFZ Enzyme Linked... · Microbiology
Oct 2022 209d
ARCHITECT Toxo IgG
K210596 · LGD Enzyme Linked... · Microbiology
May 2022 444d
GLP systems Track
K213486 · JGS Electrode, Ion Specific,... · Chemistry
Mar 2022 132d
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · QAT Brain Trauma Assessment Test · Immunology
Jan 2021 192d
CELL-DYN Emerald 22 AL System
K190294 · GKZ Counter, Differential Cell · Hematology
Mar 2019 32d
Magnesium
K181748 · JGJ Photometric Method,... · Chemistry
Sep 2018 72d
Magnesium
K173294 · JGJ Photometric Method,... · Chemistry
May 2018 214d
Abbott Architect Free T4
K173122 · CEC Radioimmunoassay, Free... · Chemistry
Oct 2017 28d
Alinity c ICT Sample Diluent
K170320 · CGZ Electrode, Ion-specific,... · Chemistry
Oct 2017 265d
Alinity i Total ?-hCG Reagent Kit, Alinity i System
K170317 · DHA System, Test, Human... · Chemistry
Oct 2017 264d
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR Hexokinase, Glucose · Chemistry
Oct 2017 260d
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · JPI Device, Hematocrit Measuring · Hematology
Aug 2017 266d
Abbott ARCHITECT Free T3
K170160 · JIT Calibrator, Secondary · Chemistry
Feb 2017 28d
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
K153375 · MRG System, Test, Vitamin D · Chemistry
Aug 2016 263d

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