The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Aso T-control.
Device ID | K904311 |
510k Number | K904311 |
Device Name: | RHEUMAGEN ASO T-CONTROL |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
Applicant | BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona, ES |
Contact | Odriozola |
Correspondent | Odriozola BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona, ES |
Product Code | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-19 |
Decision Date | 1991-01-25 |