Mardx Diagnostics, Inc. is one of 11573 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Mardx Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM, MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM, MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
8
Total
8
Cleared
0
Denied
Mardx Diagnostics, Inc. has 8 FDA 510(k) cleared medical devices. Based in Scotch Plains, US.
Historical record: 8 cleared submissions from 1989 to 1997. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Mardx Diagnostics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Mardx Diagnostics, Inc.
8 devices
Cleared
Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
Immunology
130d
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
Mar 20, 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
Immunology
64d
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