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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

71 results for "DiaSorin, Inc."
49–71 of 71
Search insights Median review: 91d Cleared: 99% Top manufacturer: DiaSorin, Inc. Lead specialty: Microbiology
Cleared Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · LOL
DiaSorin, Inc.
Microbiology · 108d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480 · MRG
DiaSorin, Inc.
Chemistry · 125d
Cleared Apr 12, 2007
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · LSR
DiaSorin, Inc.
Microbiology · 231d
Cleared Feb 26, 2007
DIASORIN LIAISON VZV IGG
K061820 · LFY
DiaSorin, Inc.
Microbiology · 243d
Cleared Oct 18, 2006
LIAISON EA IGG
K060204 · LSE
DiaSorin, Inc.
Microbiology · 265d
Cleared Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · LIP
DiaSorin, Inc.
Microbiology · 89d
Cleared Mar 31, 2006
ETI-MAX 3000
K052794 · JJF
DiaSorin, Inc.
Immunology · 179d
Cleared Apr 29, 2005
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120 · LLM
DiaSorin, Inc.
Microbiology · 465d
Cleared Jul 14, 2004
TSH-CTK-3 IRMA
K041014 · JLW
DiaSorin, Inc.
Chemistry · 85d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · CEW
DiaSorin, Inc.
Chemistry · 108d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · MRG
DiaSorin, Inc.
Chemistry · 154d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · MRG
DiaSorin, Inc.
Chemistry · 110d
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118 · DFC
DiaSorin, Inc.
Chemistry · 18d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291 · LFX
DiaSorin, Inc.
Microbiology · 132d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · LIP
DiaSorin, Inc.
Microbiology · 139d
Cleared Nov 17, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DFC
DiaSorin, Inc.
Chemistry · 16d
Cleared Jul 12, 1999
ETI-EA-G ASSAY
K992191 · LSE
DiaSorin, Inc.
Microbiology · 14d
Cleared Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660 · LSE
DiaSorin, Inc.
Microbiology · 21d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · LJN
DiaSorin, Inc.
Microbiology · 18d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708 · DFC
DiaSorin, Inc.
Chemistry · 241d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DDG
DiaSorin, Inc.
Immunology · 46d
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · LFZ
DiaSorin, Inc.
Microbiology · 176d
Cleared Nov 16, 1998
25-HYDROXYVITAMIN D 125I RIA KIT
K983617 · LCI
DiaSorin, Inc.
Chemistry · 32d