Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories - FDA 510(k) Cleared Devices

883 submissions · 868 cleared · Since 1976
883
Total
868
Cleared
0
Denied
883 devices
551-575 of 883
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646 · LDJ
Chemistry · 35d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · LIQ
Microbiology · 45d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Chemistry · 68d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · DIF
Toxicology · 103d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944 · JFJ
Chemistry · 56d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483 · DIS
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · LCL
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Toxicology · 24d
Cleared Sep 02, 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · CGX
Chemistry · 15d
Cleared Aug 26, 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · KNT
Gastroenterology & Urology · 106d
Cleared Aug 25, 1987
ABBOTT A-GENT IRON REAGENT KIT
K873120 · CFM
Chemistry · 15d
Cleared Aug 21, 1987
VISION(R) TOTAL BILIRUBIN
K872487 · CIG
Chemistry · 59d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996 · LCX
Chemistry · 84d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175 · LBZ
Chemistry · 66d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Immunology · 28d
Cleared Jul 27, 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · FRN
General Hospital · 83d
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593 · JHG
Chemistry · 87d
Cleared Jul 09, 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · JGJ
Chemistry · 22d
Cleared Jun 17, 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · KHS
Chemistry · 16d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645 · DIC
Chemistry · 44d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739 · JHI
Chemistry · 83d

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