K123947 is an FDA 510(k) clearance for the ARCHITECT IVANCOMYCIN. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Biokit, S.A. (Llissa D'Amunt, Barcelona, ES). The FDA issued a Cleared decision on August 29, 2013, 251 days after receiving the submission on December 21, 2012.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K123947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2012 |
| Decision Date | August 29, 2013 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |