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
101-125 of 883
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · CJE
Chemistry · 42d
Cleared Dec 16, 2002
ABBOTT ARCHITECT FOLATE
K023397 · CGN
Chemistry · 68d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Chemistry · 55d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Chemistry · 57d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Chemistry · 68d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Chemistry · 65d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Chemistry · 63d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
General Hospital · 27d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Cardiovascular · 35d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
General Hospital · 15d
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Toxicology · 195d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Toxicology · 195d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Toxicology · 184d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · LAF
Toxicology · 188d
Cleared Mar 13, 2002
COCAINE
K013004 · DIO
Toxicology · 188d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096 · LCM
Toxicology · 177d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143 · JXM
Toxicology · 174d
Cleared Mar 13, 2002
CANNABINOIDS
K013247 · LDJ
Toxicology · 166d
Cleared Mar 13, 2002
OPIATES
K013314 · DJG
Toxicology · 160d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Chemistry · 176d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Toxicology · 51d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Hematology · 28d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Chemistry · 112d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Hematology · 68d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · FRN
General Hospital · 26d

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