LIAISON® CMV IgG And LIAISON® CMV IgG Serum Control Set

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

DiaSorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison® Cmv Igg And Liaison® Cmv Igg Serum Control Set.

Pre-market Notification Details

• Device ID: K162969
• 510k Number: K162969
• Device Name: LIAISON® CMV IgG And LIAISON® CMV IgG Serum Control Set
• Classification: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
• Applicant: DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285
• Contact: John Walter
• Correspondent: John C. Walter; DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285
• Product Code: LFZ
• CFR Regulation Number: 866.3175 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-24
• Decision Date: 2017-01-06
• Summary: summary