The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Quantex Crp Plus (latex, Buffer, Standard, Control.
Device ID | K896272 |
510k Number | K896272 |
Device Name: | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL |
Classification | System, Test, C-reactive Protein |
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 | DCN |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1989-11-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613647001288 | K896272 | 000 |
00613647001271 | K896272 | 000 |
00006136471288 | K896272 | 000 |
00006136471271 | K896272 | 000 |
08426950589365 | K896272 | 000 |