Medical Device Manufacturer · US , Miami , FL

Diamedix Corp.

68 submissions · 68 cleared · Since 1986
68
Total
68
Cleared
0
Denied

Diamedix Corp. — FDA 510(k) Submissions

Diamedix Corp. has submitted 68 FDA 510(k) premarket notifications since 1986, of which 68 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Enzyme Linked Immunoabsorbent Assay, Rubella, Reagent, Borrelia Serological Reagent, Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, System, Test, Rheumatoid Factor . Use the specialty filter in the sidebar to narrow results.

68 devices
1–25 of 68
MAGO 4S
K093101 · LFX Enzyme Linked... · Microbiology
Jan 2011 477d
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR System, Test, Rheumatoid... · Immunology
Jul 2002 68d
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV System,test,antibodies,b2... · Immunology
Jan 2002 39d
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV System,test,antibodies,b2... · Immunology
Dec 2001 46d
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · MID System, Test,... · Immunology
Oct 2001 86d
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · MID System, Test,... · Immunology
Oct 2001 86d
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST Antibodies, Gliadin · Immunology
Sep 2001 38d
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST Antibodies, Gliadin · Immunology
Sep 2001 38d
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053 · MID System, Test,... · Immunology
Aug 2001 49d
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · LGC Enzyme Linked... · Microbiology
Nov 2000 126d
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX Enzyme Linked... · Microbiology
Aug 2000 62d
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO Antigen, Iha,... · Microbiology
Aug 2000 56d
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD Enzyme Linked... · Microbiology
Jul 2000 32d
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · LRM Anti-dna Antibody... · Immunology
Feb 2000 50d
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · LKJ Antinuclear Antibody,... · Immunology
Oct 1999 24d
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · LSE Epstein-barr Virus, Other · Microbiology
Mar 1999 286d
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · GNP Antiserum, Cf,... · Microbiology
Feb 1999 270d
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · GNP Antiserum, Cf,... · Microbiology
Feb 1999 270d
IS-RUBELLA IGG TEST SYSTEM
K981729 · LFX Enzyme Linked... · Microbiology
Jan 1999 258d
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · LGC Enzyme Linked... · Microbiology
Sep 1998 172d
IS-VZU IGG TEST SYSTEM
K981867 · LFY Enzyme Linked... · Microbiology
Sep 1998 123d
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ Enzyme Linked... · Microbiology
Sep 1998 174d
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · LGD Enzyme Linked... · Microbiology
Aug 1998 116d
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL Extractable Antinuclear... · Immunology
Apr 1998 55d
DIAMEDIX IS-RF TEST SYSTEM
K974889 · DHR System, Test, Rheumatoid... · Immunology
Mar 1998 66d
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