RUBAGEN

Latex Agglutination Assay, Rubella

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rubagen.

Pre-market Notification Details

• Device ID: K893755
• 510k Number: K893755
• Device Name: RUBAGEN
• Classification: Latex Agglutination Assay, Rubella
• Applicant: BIOKIT USA, INC. LLISSA D'AMUNT 08186 Barcelona, ES
• Contact: Castells
• Correspondent: Castells; BIOKIT USA, INC. LLISSA D'AMUNT 08186 Barcelona, ES
• Product Code: LQN
• CFR Regulation Number: 866.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-05-19
• Decision Date: 1989-08-21