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"
289–312 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · MKZ
Abbott Laboratories
Microbiology · 802d
Cleared Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
K953761 · LFH
Abbott Laboratories
Toxicology · 103d
Cleared Nov 13, 1995
AXSYM METHADONE
K953499 · DJR
Abbott Laboratories
Toxicology · 110d
Cleared Oct 26, 1995
AXSYM PHENCYCLIDINE II
K953534 · LCM
Abbott Laboratories
Toxicology · 91d
Cleared Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Oct 19, 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · GKZ
Abbott Laboratories
Hematology · 248d
Cleared Oct 17, 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · FRN
Abbott Laboratories
General Hospital · 77d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · DKZ
Abbott Laboratories
Toxicology · 95d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029 · JHI
Abbott Laboratories
Chemistry · 38d
Cleared Sep 29, 1995
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · KHG
Abbott Laboratories
Hematology · 102d
Cleared Sep 27, 1995
AXSYM REA ETHANOL
K953765 · DML
Abbott Laboratories
Toxicology · 47d
Cleared Sep 25, 1995
AXSYM PHENYTOIN II
K953840 · LGR
Abbott Laboratories
Toxicology · 40d
Cleared Sep 25, 1995
AXSYM DIGOXIN II
K953718 · KXT
Abbott Laboratories
Toxicology · 47d
Cleared Sep 19, 1995
ADI SYSTEM
K933825 · FRN
Abbott Laboratories
General Hospital · 775d
Cleared Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094 · LDP
Abbott Laboratories
Toxicology · 52d
Cleared Aug 24, 1995
AXSYM THEOPHYLLINE II
K953016 · LGS
Abbott Laboratories
Toxicology · 56d
Cleared Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571 · GTZ
Abbott Laboratories
Microbiology · 280d
Cleared Aug 08, 1995
AXSYM SALICYLATE
K951290 · DKJ
Abbott Laboratories
Toxicology · 140d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289 · DIO
Abbott Laboratories
Toxicology · 134d
Cleared Aug 01, 1995
IMX TOXO IGG
K951636 · LGD
Abbott Laboratories
Microbiology · 116d
Cleared Jul 19, 1995
IMX DIGOXIN
K952079 · KXT
Abbott Laboratories
Toxicology · 77d
Cleared Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
K952148 · JLW
Abbott Laboratories
Chemistry · 52d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566 · JJE
Abbott Laboratories
Chemistry · 231d
Cleared Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · LCP
Abbott Laboratories
Hematology · 526d