The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Ivancomycin Reagents And Architect Ivancomycin Calibrators, Models: 1p30-25 And 1p30-01.
| Device ID | K072036 |
| 510k Number | K072036 |
| Device Name: | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 |
| Classification | Radioimmunoassay, Vancomycin |
| 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 | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-25 |
| Decision Date | 2008-03-19 |
| Summary: | summary |