RUBAGEN
Latex Agglutination Assay, Rubella
BIOKIT USA, INC.
The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rubagen.
Pre-market Notification Details
| Device ID | K893755 |
| 510k Number | K893755 |
| Device Name: | RUBAGEN |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | BIOKIT USA, INC. LLISSA D'AMUNT 08186 Barcelona, ES |
| Contact | Castells |
| Correspondent | Castells BIOKIT USA, INC. LLISSA D'AMUNT 08186 Barcelona, ES |
| Product Code | LQN |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-19 |
| Decision Date | 1989-08-21 |
Trademark Results [RUBAGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RUBAGEN 74021366 1626507 Live/Registered |
Biokit USA Inc. 1990-01-22 |
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