Abbott Laboratories - FDA 510(k) Cleared Devices
882
Total
867
Cleared
0
Denied
FDA 510(k) cleared devices by Abbott Laboratories Hematology ✕
45 devices
Cleared
Feb 20, 2025
Alinity h-series System
Hematology
126d
Cleared
Aug 04, 2023
Alinity h-series System
Hematology
576d
Cleared
Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
Hematology
528d
Cleared
Mar 15, 2019
CELL-DYN Emerald 22 AL System
Hematology
32d
Cleared
Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
Hematology
266d
Cleared
Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
Hematology
315d
Cleared
Feb 04, 2009
CELL-DYN EMERALD SYSTEM
Hematology
251d
Cleared
Jul 10, 2006
CELL-DYN RUBY SYSTEM
Hematology
26d
Cleared
Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
Hematology
70d
Cleared
May 12, 2003
CELL-DYN 1800 SYSTEM
Hematology
82d
Cleared
Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
Hematology
28d
Cleared
Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
Hematology
68d
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