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"
529–552 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1998
CREA
K981799 · CGX
Abbott Laboratories
Chemistry · 62d
Cleared Jul 22, 1998
TIBC
K981654 · JMO
Abbott Laboratories
Chemistry · 72d
Cleared Jul 09, 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL,...
K981706 · JIX
Abbott Laboratories
Chemistry · 56d
Cleared Jun 29, 1998
AST
K981843 · CIT
Abbott Laboratories
Chemistry · 34d
Cleared Jun 29, 1998
CHOL
K981652 · CHH
Abbott Laboratories
Chemistry · 49d
Cleared Jun 29, 1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · GKZ
Abbott Laboratories
Hematology · 77d
Cleared Jun 25, 1998
CHOL
K981476 · CHH
Abbott Laboratories
Chemistry · 62d
Cleared Jun 22, 1998
ALKP
K981806 · CJE
Abbott Laboratories
Chemistry · 32d
Cleared Jun 22, 1998
AMM
K981467 · JIF
Abbott Laboratories
Chemistry · 60d
Cleared Jun 19, 1998
URIC ACID
K981766 · CDO
Abbott Laboratories
Chemistry · 31d
Cleared Jun 16, 1998
PHOS
K981759 · CEO
Abbott Laboratories
Chemistry · 28d
Cleared Jun 16, 1998
CA
K981578 · CJY
Abbott Laboratories
Chemistry · 43d
Cleared Jun 12, 1998
ALBG
K981758 · CIX
Abbott Laboratories
Chemistry · 24d
Cleared Jun 12, 1998
PHOS
K981118 · CEO
Abbott Laboratories
Chemistry · 77d
Cleared Jun 11, 1998
HDL
K981580 · LBS
Abbott Laboratories
Chemistry · 38d
Cleared Jun 08, 1998
CO2
K981840 · KHS
Abbott Laboratories
Chemistry · 13d
Cleared Jun 08, 1998
IRON
K981581 · CFM
Abbott Laboratories
Chemistry · 35d
Cleared Jun 08, 1998
AMY
K981216 · JFJ
Abbott Laboratories
Chemistry · 66d
Cleared May 29, 1998
CREATININE (CREA)
K981240 · CGX
Abbott Laboratories
Chemistry · 53d
Cleared May 27, 1998
ALBG
K981468 · CIX
Abbott Laboratories
Chemistry · 34d
Cleared May 27, 1998
ALBP
K981457 · CJW
Abbott Mfg., Inc.
Chemistry · 34d
Cleared May 20, 1998
TIBC
K981279 · JMO
Abbott Laboratories
Chemistry · 42d
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · CJE
Abbott Laboratories
Chemistry · 44d
Cleared May 18, 1998
LD-1
K981338 · JGF
Abbott Laboratories
Chemistry · 35d