The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Dhea-s Calibrators (a-f) And Controls (low, Medium And High).
| Device ID | K060027 |
| 510k Number | K060027 |
| Device Name: | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-04 |
| Decision Date | 2006-01-26 |
| Summary: | summary |