Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

68 results for "Diamedix Corp."
1–24 of 68
Search insights Median review: 66d Cleared: 100% Top manufacturer: Diamedix Corp. Lead specialty: Immunology
Cleared Jan 21, 2011
MAGO 4S
K093101 · LFX
Diamedix Corp.
Microbiology · 477d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR
Diamedix Corp.
Immunology · 68d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV
Diamedix Corp.
Immunology · 39d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV
Diamedix Corp.
Immunology · 46d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · MID
Diamedix Corp.
Immunology · 86d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST
Diamedix Corp.
Immunology · 38d
Cleared Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053 · MID
Diamedix Corp.
Immunology · 49d
Cleared Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · LGC
Diamedix Corp.
Microbiology · 126d
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX
Diamedix Corp.
Microbiology · 62d
Cleared Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO
Diamedix Corp.
Microbiology · 56d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Feb 18, 2000
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · LRM
Diamedix Corp.
Immunology · 50d
Cleared Oct 25, 1999
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · LKJ
Diamedix Corp.
Immunology · 24d
Cleared Mar 04, 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · LSE
Diamedix Corp.
Microbiology · 286d
Cleared Feb 16, 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Jan 28, 1999
IS-RUBELLA IGG TEST SYSTEM
K981729 · LFX
Diamedix Corp.
Microbiology · 258d
Cleared Sep 29, 1998
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · LGC
Diamedix Corp.
Microbiology · 172d
Cleared Sep 28, 1998
IS-VZU IGG TEST SYSTEM
K981867 · LFY
Diamedix Corp.
Microbiology · 123d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ
Diamedix Corp.
Microbiology · 174d
Cleared Aug 21, 1998
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · LGD
Diamedix Corp.
Microbiology · 116d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL
Diamedix Corp.
Immunology · 55d