The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Rf T-control.
Device ID | K904310 |
510k Number | K904310 |
Device Name: | RHEUMAGEN RF T-CONTROL |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-19 |
Decision Date | 1991-05-31 |