The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Quantex Rf Plus (latex, Buffer Standard, Control).
Device ID | K896271 |
510k Number | K896271 |
Device Name: | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1989-11-08 |