Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

897 results for "Abbott Laboratories"
1–24 of 897
Cleared Jul 09, 2025
ARCHITECT iGentamicin
K243500 · LCD
Abbott Laboratories
Toxicology · 239d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168 · LFX
Abbott Laboratories
Microbiology · 263d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468 · CJE
Abbott Laboratories Diagnostics Division
Chemistry · 239d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932 · LGD
Abbott Laboratories
Microbiology · 260d
Cleared Sep 29, 2023
TBI
K232669 · QAT
Abbott Laboratories
Immunology · 28d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 04, 2023
Alinity h-series System
K220031 · GKZ
Abbott Laboratories
Hematology · 576d
Cleared Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · GJS
Abbott Laboratories
Hematology · 528d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c...
K230790 · DHA
Abbott Laboratories
Chemistry · 58d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 27d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602 · QAT
Abbott Laboratories
Immunology · 90d
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · LFZ
Abbott Laboratories
Microbiology · 209d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · LGD
Abbott Laboratories
Microbiology · 444d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 625d
Cleared Mar 10, 2022
GLP systems Track
K213486 · JGS
Abbott Laboratories
Chemistry · 132d
Cleared Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · QAT
Abbott Laboratories
Immunology · 192d
Cleared Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 88d
Cleared Mar 15, 2019
CELL-DYN Emerald 22 AL System
K190294 · GKZ
Abbott Laboratories
Hematology · 32d
Cleared Sep 12, 2018
Magnesium
K181748 · JGJ
Abbott Laboratories
Chemistry · 72d
Cleared May 18, 2018
Magnesium
K173294 · JGJ
Abbott Laboratories
Chemistry · 214d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122 · CEC
Abbott Laboratories
Chemistry · 28d
Cleared Oct 24, 2017
Alinity c ICT Sample Diluent
K170320 · CGZ
Abbott Laboratories
Chemistry · 265d