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
326-350 of 883
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384 · CDX
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · JLW
Chemistry · 284d
Cleared Jun 21, 1994
AXSYM TOTAL T3
K934517 · CDP
Toxicology · 274d
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · CEC
Chemistry · 272d
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373 · KLS
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM CARBAMAZEPHINE
K935374 · KLT
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM PHENYTOIN ASSAY
K935375 · LGR
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611 · JJX
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · CGJ
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673 · JHI
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM PROLACTIN
K935675 · CFT
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847 · DBF
Immunology · 195d
Cleared Jun 21, 1994
AXSYM CK-MB
K935924 · JHW
Chemistry · 190d
Cleared Jun 21, 1994
AXSYM VANCOMYCIN
K940595 · LEH
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM PHENOBARBITAL
K940596 · LGQ
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM(TM) QUINIDINE
K940682 · LGI
Chemistry · 131d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329 · DQO
Cardiovascular · 35d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254 · DQO
Cardiovascular · 94d
Cleared Jun 09, 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · KNT
Gastroenterology & Urology · 609d
Cleared Jun 09, 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · KNT
Gastroenterology & Urology · 363d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · FPA
General Hospital · 288d
Cleared Mar 28, 1994
ABBOTT SMART CAP
K921818 · KDJ
Gastroenterology & Urology · 712d
Cleared Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · FPA
General Hospital · 263d
Cleared Mar 14, 1994
HI-FLO INFUSION PUMP
K934671 · FRN
General Hospital · 166d
Cleared Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
K925418 · FPA
General Hospital · 372d

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