Abbott Laboratories - FDA 510(k) Cleared Devices
883
Total
868
Cleared
0
Denied
883 devices
Cleared
Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
Toxicology
46d
Cleared
Aug 23, 1996
AXSYM TOXO IGM
Microbiology
326d
Cleared
Aug 16, 1996
AXSYM TOXO IGG ANTIBODY ASSAY
Microbiology
319d
Cleared
Jul 16, 1996
IMX RUBELLA IGG
Microbiology
470d
Cleared
Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
General Hospital
325d
Cleared
May 30, 1996
IMX SELECT CHLAMYDIA
Microbiology
891d
Cleared
May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
General Hospital
267d
Cleared
May 29, 1996
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
General Hospital
148d
Cleared
May 20, 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
Hematology
196d
Cleared
May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
Microbiology
242d
Cleared
May 09, 1996
AXSYM VANCOMYCIN II
Toxicology
134d
Cleared
May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
Microbiology
881d
Cleared
May 06, 1996
SNAPDOSE DEVICE
General Hospital
161d
Cleared
Apr 24, 1996
AXSYM N-ACETYLPROCAINAMIDE
Toxicology
148d
Cleared
Apr 02, 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
Toxicology
126d
Cleared
Mar 07, 1996
AXSYM PROGESTERONE
Chemistry
126d
Cleared
Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
Microbiology
220d
Cleared
Jan 18, 1996
ABBOTT XL3M INFUSION PUMP
General Hospital
213d
Cleared
Dec 29, 1995
AXSYM DIGITOXIN
Toxicology
99d
Cleared
Dec 13, 1995
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
General Hospital
127d
Cleared
Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
Microbiology
802d
Cleared
Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
Toxicology
103d
Cleared
Nov 13, 1995
AXSYM METHADONE
Toxicology
110d
Cleared
Oct 26, 1995
AXSYM PHENCYCLIDINE II
Toxicology
91d
Cleared
Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
General Hospital
84d
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