The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Quantia Beta-2 Microglobulin, Model: 302822307.
| Device ID | K072078 |
| 510k Number | K072078 |
| Device Name: | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BIOKIT S.A. CAN MALE S/N LLICA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. CAN MALE S/N LLICA D'AMUNT Barcelona, ES 08186 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-12-19 |
| Summary: | summary |