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"
1033–1056 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 15, 1985
TDX AMYLASE
K853978 · CIX
Abbott Laboratories
Chemistry · 19d
Cleared Oct 15, 1985
VISION THEOPHYLLINE
K853834 · KLS
Abbott Laboratories
Toxicology · 29d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · JHI
Abbott Laboratories
Chemistry · 33d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472 · LKT
Abbott Laboratories
Microbiology · 98d
Cleared Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · GKZ
Abbott Diagnostics
Hematology · 105d
Cleared Sep 16, 1985
TDX REA BUN
K853677 · CDQ
Abbott Laboratories
Chemistry · 12d
Cleared Sep 06, 1985
ABBOTT CATION SUPPLEMENT SOLUTION
K853546 · JSK
Abbott Laboratories
Microbiology · 11d
Cleared Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · JPK
Abbott Diagnostics
Hematology · 91d
Cleared Aug 12, 1985
TD TRICYCLIC ANTIDEPRESSANTS
K853113 · LFG
Abbott Laboratories
Toxicology · 19d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950 · CEM
Abbott Laboratories
Chemistry · 158d
Cleared Aug 05, 1985
TDX CORTISOL
K852927 · JFT
Abbott Laboratories
Chemistry · 27d
Cleared Jul 22, 1985
TDX REA TRIGLYCERIDES
K852556 · JGW
Abbott Laboratories
Chemistry · 35d
Cleared Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · DEW
Abbott Laboratories
Immunology · 27d
Cleared Jul 09, 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Jul 09, 1985
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · LGD
Abbott Laboratories
Microbiology · 147d
Cleared Jul 05, 1985
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · GKH
Abbott Diagnostics
Hematology · 31d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930 · JMO
Abbott Laboratories
Chemistry · 22d
Cleared May 20, 1985
TDX TOTAL T3
K851676 · CDP
Abbott Laboratories
Chemistry · 27d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622 · LGC
Abbott Laboratories
Immunology · 248d
Cleared Apr 30, 1985
TDX ANALYZER W/NEPHELOMETRY CAROUSEL
K851253 · JQX
Abbott Laboratories
Chemistry · 33d
Cleared Apr 29, 1985
A-JUST TURBIDITY METER
K851234 · JQX
Abbott Laboratories
Microbiology · 34d
Cleared Apr 08, 1985
STREP A QUICK
K850831 · GTZ
Abbott Laboratories
Microbiology · 38d
Cleared Apr 08, 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256 · GTZ
Abbott Laboratories
Microbiology · 76d
Cleared Apr 03, 1985
ABBOTT TDT EIA
K843908 · CIG
Abbott Laboratories
Chemistry · 182d