Atlas FDA

General Atomics

6 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DIAZYME LP(A) ASSAY (K082488)General Atomics2009-01-13
DIAZYME APOLIPOPROTEIN A-1 ASSAY (K072977)General Atomics2008-07-16
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523)General Atomics2008-01-22
HBA1C ENZYMATIC ASSAY (K050178)General Atomics2005-06-28
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (K042448)General Atomics2004-10-29
DIAZYME LITHIUM ENZYMATIC ASSAY KIT (K033360)General Atomics2003-12-23

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Every clearance here is in the API, with alerts when new ones post.