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"
889–912 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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