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

901 results for "Abbott Laboratories"
481–504 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Abbott Laboratories
Microbiology · 178d