The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Quantia La(a).
| Device ID | K050487 |
| 510k Number | K050487 |
| Device Name: | QUANTIA LA(A) |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | DFC |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740054267 | K050487 | 000 |
| 00380740153847 | K050487 | 000 |
| 00380740156435 | K050487 | 000 |