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 |