Mardx Diagnostics, Inc.
Medical device manufacturer in Carlsbad, CA.
8510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K964787 | Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test SystemLLL · Traditional | 04/08/1997SE |
| K951709 | Mardx Lyme Disease (Igm) Marblot Strip Test SystemLSR · Traditional | 06/07/1996SE |
| K950829 | Mardx Lyme Disease (Igg) Marblot Strip Test SystemLSR · Traditional | 06/05/1996SE |
| K960182 | Dsdna Immunoglobulin Eia Test SystemLRM · Traditional | 03/20/1996SE |
| K894293 | Mardx Lyme Disease Eia (Igm) Test SystemLSR · Traditional | 08/21/1989SE |
| K894224 | Mardx Lyme Disease Eia (Igg) Test SystemLSR · Traditional | 08/21/1989SE |
| K892206 | Mardx Llyme Disease Eia (Igg & Igm) Test SystemLSR · Traditional | 08/15/1989SE |
| K890053 | Mardx Lyme Disease Igg Ifa Test SystemLSR · Traditional | 04/18/1989SE |