The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Idigoxin And Architect Idigoxin Calibrators, Models 1p32-25 And Ip32-01.
| Device ID | K082953 |
| 510k Number | K082953 |
| Device Name: | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 |
| Classification | Enzyme Immunoassay, Digoxin |
| 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 | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-03 |
| Decision Date | 2008-12-22 |
| Summary: | summary |