FDA 510(k)

LIAISON® Folate

K-Number: K192586 · 2020-05-06

Decision Date2020-05-06

Product CodeCGN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LIAISON® Folate is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-05-06 under approval number K192586. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON® Folate?

LIAISON® Folate is a medical device that received FDA 510(k) clearance on 2020-05-06. It is manufactured by DiaSorin, Inc.. The 510(k) number is K192586.

When was LIAISON® Folate approved by the FDA?

LIAISON® Folate received FDA 510(k) clearance on 2020-05-06, under approval number K192586.

What company makes LIAISON® Folate?

LIAISON® Folate is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON® Folate?

The FDA product code for LIAISON® Folate is CGN.

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

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Related Devices (Code: CGN)

K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme Laboratories K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. K223590Access Folate AssayBeckman Coulter, Inc. K233060Elecsys Folate IIIRoche Diagnostics

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.