The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect I Theophylline Reagents And Calibrators (a-f).
| Device ID | K070810 |
| 510k Number | K070810 |
| Device Name: | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| 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 | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-06-08 |
| Summary: | summary |