The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect C-peptide Calibrators, And Architect C-peptide Controls, Models 3l53-01, 3l53-10.
| Device ID | K082141 |
| 510k Number | K082141 |
| Device Name: | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-09-03 |
| Summary: | summary |