FDA 510(k)

LIAISON Ferritin

K-Number: K193650 · 2021-09-14

Decision Date2021-09-14

Product CodeDBF

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

LIAISON Ferritin is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-09-14 under approval number K193650. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Ferritin?

LIAISON Ferritin is a medical device that received FDA 510(k) clearance on 2021-09-14. It is manufactured by DiaSorin, Inc.. The 510(k) number is K193650.

When was LIAISON Ferritin approved by the FDA?

LIAISON Ferritin received FDA 510(k) clearance on 2021-09-14, under approval number K193650.

What company makes LIAISON Ferritin?

LIAISON Ferritin is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON Ferritin?

The FDA product code for LIAISON Ferritin is DBF.

Other Devices by DiaSorin, Inc.

K160650LIAISON HAV IgM, LIAISON Control HAV IgM K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set K161526LIAISON CMV IgM Serum Control Set K161522LIAISON EBV IgM Serum Control Set K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

View all 41 devices →

Related Devices (Code: DBF)

K171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc. K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SAS

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.