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

1,305 results for "abbott"
961–984 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996 · LCX
Abbott Laboratories
Chemistry · 84d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175 · LBZ
Abbott Laboratories
Chemistry · 66d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Abbott Laboratories
Immunology · 28d
Cleared Aug 06, 1987
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · GKZ
Abbott Diagnostics
Hematology · 24d
Cleared Jul 27, 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593 · JHG
Abbott Laboratories
Chemistry · 87d
Cleared Jul 09, 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · JGJ
Abbott Laboratories
Chemistry · 22d
Cleared Jun 17, 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · KHS
Abbott Laboratories
Chemistry · 16d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645 · DIC
Abbott Laboratories
Chemistry · 44d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739 · JHI
Abbott Laboratories
Chemistry · 83d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461 · LBS
Abbott Laboratories
Chemistry · 30d
Cleared May 13, 1987
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240 · JGF
Abbott Laboratories
Chemistry · 47d
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · LJC
Abbott Laboratories
Microbiology · 140d
Cleared Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Mar 31, 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · JIF
Abbott Laboratories
Chemistry · 33d
Cleared Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ
Abbott Diagnostics
Hematology · 55d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131 · DCK
Abbott Laboratories
Immunology · 146d
Cleared Mar 13, 1987
TDXR CANNABINOIDS
K864751 · LDJ
Abbott Laboratories
Chemistry · 98d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · GTY
Abbott Laboratories
Microbiology · 83d
Cleared Feb 06, 1987
I.V. SET WITH DUAL-CHANNEL CASSETTE
K865060 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
I.V. SET W/SINGLE-CHANNEL CASSETTE
K865059 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K865058 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 04, 1987
ADX(TM) ANALYZER
K864566 · JJQ
Abbott Laboratories
Chemistry · 77d