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 |