Mardx Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
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Total Devices8
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM | LLL | 1997-04-08 | View |
| 510(k) | K951709 | MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM | LSR | 1996-06-07 | View |
| 510(k) | K950829 | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM | LSR | 1996-06-05 | View |
| 510(k) | K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | LRM | 1996-03-20 | View |
| 510(k) | K894224 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | LSR | 1989-08-21 | View |
| 510(k) | K894293 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | LSR | 1989-08-21 | View |
| 510(k) | K892206 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM | LSR | 1989-08-15 | View |
| 510(k) | K890053 | MARDX LYME DISEASE IGG IFA TEST SYSTEM | LSR | 1989-04-18 | View |
No matching devices.
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