FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
1033–1056 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Abbott Diagnostics
Hematology · 89d
Cleared Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042 · FKX
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · DHR
Abbott Laboratories
Chemistry · 29d
Cleared Feb 21, 1985
CAPD STAGED CONNECTOR
K845041 · FKO
Abbott Laboratories
Gastroenterology & Urology · 55d
Cleared Feb 15, 1985
NUTRIMIX EMPTY CONTAINER
K844077 · KPE
Abbott Laboratories
General Hospital · 119d
Cleared Feb 12, 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · JHJ
Abbott Laboratories
Chemistry · 56d