General Atomics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
General Atomics - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
General Atomics has 6 FDA 510(k) cleared medical devices. Based in San Diego, US.
Historical record: 6 cleared submissions from 2003 to 2009. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by General Atomics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - General Atomics
6 devices
Cleared
Jan 13, 2009
DIAZYME LP(A) ASSAY
Chemistry
138d
Cleared
Jul 16, 2008
DIAZYME APOLIPOPROTEIN A-1 ASSAY
Chemistry
268d
Cleared
Jan 22, 2008
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
Chemistry
137d
Cleared
Jun 28, 2005
HBA1C ENZYMATIC ASSAY
Chemistry
153d
Cleared
Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
Chemistry
50d
Cleared
Dec 23, 2003
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
Chemistry
63d