The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Modified Rubagen.
| Device ID | K896433 |
| 510k Number | K896433 |
| Device Name: | MODIFIED RUBAGEN |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona, ES |
| Contact | Ignacio Odriozola |
| Correspondent | Ignacio Odriozola BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN 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 | 1989-11-09 |
| Decision Date | 1989-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647001226 | K896433 | 000 |
| 00613647001219 | K896433 | 000 |
| 08426950590569 | K896433 | 000 |
| 00006136471226 | K896433 | 000 |
| 00006136471219 | K896433 | 000 |