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 |