FDA 510(k) Applications Submitted by MARDX DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K950829 02/23/1995 MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM MARDX DIAGNOSTICS, INC.
K951709 04/13/1995 MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM MARDX DIAGNOSTICS, INC.
K964787 11/29/1996 MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM MARDX DIAGNOSTICS, INC.
K960182 01/16/1996 DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM MARDX DIAGNOSTICS, INC.


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