The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Lp(a) Calibrators, And Lp(a) Controls.
| Device ID | K132400 |
| 510k Number | K132400 |
| Device Name: | LP(A) CALIBRATORS, AND LP(A) CONTROLS |
| Classification | Calibrator, Secondary |
| Applicant | BIOKIT S.A. CAN MALE, S/N Llissa D'amunt, Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. CAN MALE, S/N Llissa D'amunt, Barcelona, ES 08186 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2013-12-19 |
| Summary: | summary |