General Atomics
Medical device manufacturer in Poway, CA.
6510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | 01/13/2009SE |
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | 07/16/2008SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | 01/22/2008SE |
| K050178 | HBA1C Enzymatic AssayLCP · Traditional | 06/28/2005SE |
| K042448 | Diazyme Homocysteine Enzymatic Assay KitJJX · Traditional | 10/29/2004SE |
| K033360 | Diazyme Lithium Enzymatic Assay KitJII · Traditional | 12/23/2003SE |