RHEUMAGEN CRP T-CONTROL

C-reactive Protein, Antigen, Antiserum, And Control

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Crp T-control.

Pre-market Notification Details

• Device ID: K904312
• 510k Number: K904312
• Device Name: RHEUMAGEN CRP T-CONTROL
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186
• Contact: Odriozola
• Correspondent: Odriozola; BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-09-19
• Decision Date: 1990-10-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08426950590460	K904312	000