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"
841–864 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · CFR
Abbott Laboratories
Chemistry · 78d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · CHH
Abbott Laboratories
Chemistry · 53d
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222 · JJE
Abbott Laboratories
Toxicology · 101d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182 · JHI
Abbott Laboratories
Chemistry · 102d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · DKZ
Abbott Laboratories
Toxicology · 38d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · CIC
Abbott Laboratories
Chemistry · 70d
Cleared Sep 13, 1989
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · CIT
Abbott Laboratories
Chemistry · 89d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Aug 25, 1989
ADX COCAINE METABOLITE
K890788 · DIO
Abbott Laboratories
Toxicology · 191d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743 · DIC
Abbott Laboratories
Chemistry · 193d
Cleared Aug 25, 1989
ADX CANNABINOIDS
K890693 · LDJ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · DKZ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691 · JXM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690 · DIS
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM OPIATES
K890689 · DGJ
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688 · LCM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 21, 1989
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · JQW
Abbott Laboratories
Chemistry · 74d
Cleared Aug 17, 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · GCX
Abbott Laboratories
General Hospital · 92d
Cleared Aug 17, 1989
LIFECARE MICRO PUMP
K883645 · FRN
Abbott Laboratories
General Hospital · 357d
Cleared Aug 15, 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · JFJ
Abbott Laboratories
Chemistry · 161d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Abbott Laboratories
Hematology · 63d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776 · JJE
Abbott Laboratories
Chemistry · 73d
Cleared Jul 28, 1989
LIFECARE 75 CONTROLLER
K893487 · LDR
Abbott Laboratories
General Hospital · 85d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Abbott Laboratories
Microbiology · 70d