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General Atomics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K082488DIAZYME LP(A) ASSAYJanuary 13, 2009
K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYJuly 16, 2008
K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSJanuary 22, 2008
K050178HBA1C ENZYMATIC ASSAYJune 28, 2005
K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITOctober 29, 2004
K033360DIAZYME LITHIUM ENZYMATIC ASSAY KITDecember 23, 2003