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"
25–48 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Oct 23, 2017
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · DHA
Abbott Laboratories
Chemistry · 264d
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR
Abbott Laboratories
Chemistry · 260d
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · JPI
Abbott Laboratories
Hematology · 266d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160 · JIT
Abbott Laboratories
Chemistry · 28d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
K153375 · MRG
Abbott Laboratories
Chemistry · 263d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
K153730 · LIP
Abbott Laboratories
Microbiology · 170d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
K152155 · CDZ
Abbott Laboratories
Chemistry · 136d
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · LFR
Abott Laboratories
Chemistry · 30d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · JIT
Abbott Laboratories
Chemistry · 30d
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · NBW
Abbott Laboratories
Chemistry · 95d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · NBW
Abbott Laboratories
Chemistry · 115d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · PDJ
Abbott Laboratories
Chemistry · 434d
Cleared Apr 02, 2015
Total Bilirubin
K150510 · CIG
Abbott Laboratories
Chemistry · 34d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · NBW
Abbott Laboratories
Chemistry · 186d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · CEC
Abbott Laboratories
Chemistry · 26d
Cleared Sep 11, 2012
TESTOSTERONE TEST SYSTEM
K120009 · CDZ
Abbott Laboratories
Chemistry · 252d