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"
505–528 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417 · CEC
Abbott Laboratories
Chemistry · 52d
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212 · CDZ
Abbott Laboratories
Chemistry · 65d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · LYR
Abbott Laboratories
Microbiology · 135d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGG
K983221 · DEW
Abbott Laboratories
Immunology · 51d
Cleared Nov 04, 1998
TRF
K983167 · DDG
Abbott Laboratories
Immunology · 55d
Cleared Nov 04, 1998
IGM
K983132 · DFT
Abbott Laboratories
Immunology · 57d
Cleared Oct 23, 1998
MG
K981791 · JGJ
Abbott Laboratories
Chemistry · 155d
Cleared Oct 01, 1998
UPRO
K981295 · JGQ
Abbott Laboratories
Chemistry · 175d
Cleared Sep 28, 1998
AST
K983131 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Sep 23, 1998
NBIL
K983134 · MQM
Abbott Laboratories
Chemistry · 15d
Cleared Sep 21, 1998
UPRO
K981682 · JGQ
Abbott Laboratories
Chemistry · 131d
Cleared Sep 16, 1998
TBIL
K983133 · CIG
Abbott Laboratories
Chemistry · 8d
Cleared Aug 28, 1998
AMY
K981653 · JFJ
Abbott Laboratories
Chemistry · 109d
Cleared Aug 03, 1998
DIRECT LDL
K981303 · MRR
Abbott Laboratories
Chemistry · 115d
Cleared Aug 03, 1998
DIRECT HDL
K981224 · LBS
Abbott Laboratories
Chemistry · 122d
Cleared Jul 30, 1998
UIBC
K982041 · JMO
Abbott Laboratories
Chemistry · 50d
Cleared Jul 28, 1998
UREA
K981918 · CDQ
Abbott Laboratories
Chemistry · 57d
Cleared Jul 22, 1998
DBIL
K981943 · CIG
Abbott Laboratories
Chemistry · 49d
Cleared Jul 22, 1998
AMM
K981920 · JIF
Abbott Laboratories
Chemistry · 51d
Cleared Jul 22, 1998
ALBP
K981814 · CJW
Abbott Laboratories
Chemistry · 61d