The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Quantia Beta-2 Microglobulin.
| Device ID | K050613 |
| 510k Number | K050613 |
| Device Name: | QUANTIA BETA-2 MICROGLOBULIN |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | JZG |
| Subsequent Product Code | JJS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-10 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740054199 | K050613 | 000 |
| 00380740030063 | K050613 | 000 |
| 00380740156312 | K050613 | 000 |
| 00380740156268 | K050613 | 000 |
| 00380740156374 | K050613 | 000 |
| 00380740044862 | K050613 | 000 |