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
276-300 of 883
Cleared Oct 19, 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · GKZ
Hematology · 248d
Cleared Oct 17, 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · FRN
General Hospital · 77d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · DKZ
Toxicology · 95d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029 · JHI
Chemistry · 38d
Cleared Sep 29, 1995
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · KHG
Hematology · 102d
Cleared Sep 27, 1995
AXSYM REA ETHANOL
K953765 · DML
Toxicology · 47d
Cleared Sep 25, 1995
AXSYM DIGOXIN II
K953718 · KXT
Toxicology · 47d
Cleared Sep 25, 1995
AXSYM PHENYTOIN II
K953840 · LGR
Toxicology · 40d
Cleared Sep 19, 1995
ADI SYSTEM
K933825 · FRN
General Hospital · 775d
Cleared Aug 24, 1995
AXSYM THEOPHYLLINE II
K953016 · LGS
Toxicology · 56d
Cleared Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094 · LDP
Toxicology · 52d
Cleared Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571 · GTZ
Microbiology · 280d
Cleared Aug 08, 1995
AXSYM SALICYLATE
K951290 · DKJ
Toxicology · 140d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289 · DIO
Toxicology · 134d
Cleared Aug 01, 1995
IMX TOXO IGG
K951636 · LGD
Microbiology · 116d
Cleared Jul 19, 1995
IMX DIGOXIN
K952079 · KXT
Toxicology · 77d
Cleared Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
K952148 · JLW
Chemistry · 52d
Cleared Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · LCP
Hematology · 526d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566 · JJE
Chemistry · 231d
Cleared May 23, 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · FRN
General Hospital · 309d
Cleared May 18, 1995
AXSYM BARBITURATES II U
K951253 · DIS
Toxicology · 58d
Cleared May 18, 1995
AXSYM OPIATES
K951287 · DJG
Toxicology · 58d
Cleared May 17, 1995
IMX ESTRADIOL
K951629 · JIS
Chemistry · 61d
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915 · JJE
Toxicology · 76d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286 · JXM
Toxicology · 56d

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