Mardx Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM | April 8, 1997 |
| K951709 | MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM | June 7, 1996 |
| K950829 | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM | June 5, 1996 |
| K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | March 20, 1996 |
| K894224 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | August 21, 1989 |
| K894293 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | August 21, 1989 |
| K892206 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM | August 15, 1989 |
| K890053 | MARDX LYME DISEASE IGG IFA TEST SYSTEM | April 18, 1989 |