Medical Device Manufacturer · US , Ellicott City , MD

DiaSorin, Inc. - FDA 510(k) Cleared Devices

71 submissions · 70 cleared · Since 1998

Recent clearances: LIAISON Murex HBsAg Qual, LIAISON VZV IgG HT, LIAISON Control VZV IgG HT, LIAISON Anti-HAV

71

Total

70

Cleared

1

Denied

FDA 510(k) Regulatory Record - DiaSorin, Inc. Immunology ✕

5 devices

1-5 of 5

Cleared Jul 26, 2022

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

Immunology · 228d

Cleared Sep 14, 2021

LIAISON Ferritin

Immunology · 624d

Cleared CT Dec 26, 2018

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin...

Immunology · 90d

Cleared Mar 31, 2006

Immunology · 179d

Cleared Dec 18, 1998

TRANSFERRIN SPQ III ANTIBODY REAGENT SET

Immunology · 46d