ClearanceBrief
Company ยท US

Mardx Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1997. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LSRReagent, Borrelia Serological Reagent6
LLLExtractable Antinuclear Antibody, Antigen And Control1
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 8, 1997K964787MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
Mardx Diagnostics, Inc.
LLL
Jun 7, 1996K951709MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Jun 5, 1996K950829MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Mar 20, 1996K960182DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
Mardx Diagnostics, Inc.
LRM
Aug 21, 1989K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Aug 21, 1989K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Aug 15, 1989K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Apr 18, 1989K890053MARDX LYME DISEASE IGG IFA TEST SYSTEM
Mardx Diagnostics, Inc.
LSR

Latest recalls

DateFirm and productCodeLinked 510(k)
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