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

Filters: Chemistry ×
485 results for "abbott"
169–192 of 485
Search insights Median review: 58d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · CDP
Abbott Laboratories
Chemistry · 52d
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 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
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
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 25, 1998
CHOL
K981476 · CHH
Abbott Laboratories
Chemistry · 62d