LIAISON® VCA IgG And LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG And LIAISON® EBNA IgG Serum Control Set

Epstein-barr Virus, Other

DIASORIN INC.

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

Pre-market Notification Details

• Device ID: K162961
• 510k Number: K162961
• Device Name: LIAISON® VCA IgG And LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG And LIAISON® EBNA IgG Serum Control Set
• Classification: Epstein-barr Virus, Other
• Applicant: DIASORIN INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285
• Contact: John Walter
• Correspondent: John C. Walter; DIASORIN INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285
• Product Code: LSE
• Subsequent Product Code: JJX
• Subsequent Product Code: LLM
• CFR Regulation Number: 866.3235 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-24
• Decision Date: 2017-01-05
• Summary: summary