The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Ivancomycin.
| Device ID | K123947 |
| 510k Number | K123947 |
| Device Name: | ARCHITECT IVANCOMYCIN |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | BIOKIT S.A. CAN MALE, S/N Llissa D'amunt, Barcelona, ES 08186 |
| Contact | Guillem Anglerill |
| Correspondent | Guillem Anglerill BIOKIT S.A. CAN MALE, S/N Llissa 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 | 2012-12-21 |
| Decision Date | 2013-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740105327 | K123947 | 000 |
| 00380740156237 | K123947 | 000 |