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"
529–552 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · GQG
Abbott Laboratories
Microbiology · 22d
Cleared Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · GEX
Abbott Laboratories
General & Plastic Surgery · 165d
Cleared Jun 13, 1988
VENOVALVE(TM)
K881234 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · CFJ
Abbott Laboratories
Chemistry · 55d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029 · JIN
Abbott Laboratories
Chemistry · 172d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · DYG
Abbott Laboratories
Cardiovascular · 208d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469 · LJC
Abbott Laboratories
Microbiology · 110d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Abbott Laboratories
Microbiology · 296d
Cleared May 11, 1988
IMX FERRITIN
K881345 · DGD
Abbott Laboratories
Immunology · 42d
Cleared May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · LIQ
Abbott Laboratories
Microbiology · 66d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Abbott Laboratories
Microbiology · 206d