LIAISON® Folate

Acid, Folic, Radioimmunoassay

Diasorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison® Folate.

Pre-market Notification Details

• Device ID: K192586
• 510k Number: K192586
• Device Name: LIAISON® Folate
• Classification: Acid, Folic, Radioimmunoassay
• Applicant: Diasorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285
• Contact: John C. Walter
• Correspondent: Mari Meyer; Diasorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285
• Product Code: CGN
• CFR Regulation Number: 862.1295 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-19
• Decision Date: 2020-05-06