Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

901 results for "Abbott Laboratories"
1–24 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 23, 2026
Anti-HCV Next
K262156 · MZO
Abbott Laboratories
Microbiology · 89d
Cleared Apr 28, 2026
Anti-HCV Next
K252424 · MZO
Abbott Laboratories
Microbiology · 270d
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 Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
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 CT 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