Mardx Diagnostics, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mardx Diagnostics, Inc. Microbiology ✕
6 devices
Cleared
Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
Microbiology
421d
Cleared
Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Microbiology
468d
Cleared
Aug 21, 1989
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Microbiology
63d
Cleared
Aug 21, 1989
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Microbiology
59d
Cleared
Aug 15, 1989
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
Microbiology
134d
Cleared
Apr 18, 1989
MARDX LYME DISEASE IGG IFA TEST SYSTEM
Microbiology
102d