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FDA 510(k) Applications Submitted by GENERAL ATOMICS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K082488
08/28/2008
DIAZYME LP(A) ASSAY
GENERAL ATOMICS
K072977
10/22/2007
DIAZYME APOLIPOPROTEIN A-1 ASSAY
GENERAL ATOMICS
K072523
09/07/2007
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
GENERAL ATOMICS
K033360
10/21/2003
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
GENERAL ATOMICS
K050178
01/26/2005
HBA1C ENZYMATIC ASSAY
GENERAL ATOMICS
K042448
09/09/2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
GENERAL ATOMICS
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