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"
553–576 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 21, 1988
TDX (R) AMPHETAMINE CLASS
K874770 · DKZ
Abbott Laboratories
Toxicology · 154d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087 · CDP
Abbott Laboratories
Chemistry · 97d
Cleared Apr 05, 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · CIG
Abbott Laboratories
Chemistry · 41d
Cleared Apr 05, 1988
ABBOTT IMX HTSH
K880086 · JLW
Abbott Laboratories
Chemistry · 84d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070 · JHI
Abbott Laboratories
Chemistry · 72d
Cleared Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Abbott Laboratories
Immunology · 82d
Cleared Mar 16, 1988
VISION(R) THYROXINE (T4)
K880662 · KLI
Abbott Laboratories
Chemistry · 28d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · DIO
Abbott Laboratories
Toxicology · 67d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · LDJ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · DKZ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · DIS
Abbott Laboratories
Toxicology · 57d
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · JXM
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · LCL
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
K880010 · DJG
Abbott Laboratories
Toxicology · 38d
Cleared Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · KPF
Abbott Laboratories
Gastroenterology & Urology · 119d
Cleared Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · CDT
Abbott Laboratories
Chemistry · 99d
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646 · LDJ
Abbott Laboratories
Chemistry · 35d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · LIQ
Abbott Laboratories
Microbiology · 45d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Abbott Laboratories
Chemistry · 68d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Abbott Laboratories
Toxicology · 24d