The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Quantex Aso Plus (latex,buffer Standard,control).
| Device ID | K894486 |
| 510k Number | K894486 |
| Device Name: | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| 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 | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-10-24 |