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. Microbiology ✕

42 devices

1-12 of 42

Cleared Jun 04, 2026

LIAISON Murex HBsAg Qual

Microbiology · 87d

Not Cleared Dec 23, 2025

LIAISON® XL MUREX Anti-HDV (318260)

DEN250032 · SGW

Microbiology · 146d

Cleared Oct 27, 2023

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

Microbiology · 182d

Cleared Dec 09, 2022

LIAISON Anti-HAV

Microbiology · 30d

Cleared Jul 14, 2022

LIAISON MeMed BV, LIAISON MeMed BV Control Set

Microbiology · 210d

Cleared Feb 18, 2021

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus

Microbiology · 167d

Cleared Feb 18, 2021

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus

Microbiology · 167d

Cleared Feb 09, 2021

LIAISON Anti-HAV

Microbiology · 8d

Cleared Mar 02, 2020

LIAISON Anti-HAV Assay

Microbiology · 73d

Cleared Jan 29, 2020

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

Microbiology · 89d

Cleared Oct 28, 2019

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

Microbiology · 89d

Cleared CT Aug 31, 2018

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

Microbiology · 88d

Looking for a specific device from DiaSorin, Inc.? Search by device name or K-number.

Search all DiaSorin, Inc. devices