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 the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-05-06 under 510(k) 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. The listed applicant is DiaSorin, Inc.. The 510(k) number is K192586.

When did LIAISON® Folate receive FDA 510(k) clearance?

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

Who is the listed applicant for LIAISON® Folate?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON® Folate?

The FDA product code for LIAISON® Folate is CGN.

Other records listing DiaSorin, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250039ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM PMA P220034ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX PMA P180047TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS PMA P190017Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)PMA P180049Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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Related Devices (Code: CGN)

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

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.