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"
889–912 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · KHS
Abbott Laboratories
Chemistry · 40d
Cleared Dec 22, 1988
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · KNT
Abbott Laboratories
Gastroenterology & Urology · 71d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Abbott Laboratories
Microbiology · 14d
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968 · DJR
Abbott Laboratories
Toxicology · 16d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · KRB
Abbott Laboratories
Cardiovascular · 61d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596 · CHI
Abbott Laboratories
Chemistry · 33d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566 · CEM
Abbott Laboratories
Chemistry · 31d
Cleared Dec 02, 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · DHA
Abbott Laboratories
Chemistry · 57d
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138 · CEP
Abbott Laboratories
Chemistry · 60d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730 · JXM
Abbott Laboratories
Toxicology · 90d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · DKZ
Abbott Laboratories
Chemistry · 51d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Oct 11, 1988
TDX CANNABINOIDS-GS
K883731 · LDJ
Abbott Laboratories
Toxicology · 41d
Cleared Oct 06, 1988
POCKET MANOMETER
K880599 · DXN
Abbott Laboratories
Cardiovascular · 238d
Cleared Sep 13, 1988
VISION(R) PROTHROMBIN TIME
K883441 · GJS
Abbott Laboratories
Hematology · 29d
Cleared Aug 30, 1988
VISTA INSTRUMENT
K882914 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
DTR ANALYZER
K882913 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · CFR
Abbott Laboratories
Chemistry · 64d
Cleared Aug 08, 1988
IMX CKMB
K883013 · JHY
Abbott Laboratories
Chemistry · 20d
Cleared Aug 03, 1988
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · CIG
Abbott Laboratories
Chemistry · 183d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · LJC
Abbott Laboratories
Microbiology · 150d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · LJC
Abbott Laboratories
Microbiology · 23d
Cleared Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
K882534 · LIR
Abbott Laboratories
Microbiology · 21d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233 · KXT
Abbott Laboratories
Chemistry · 40d