ARCHITECT IVANCOMYCIN— 510(k) K123947

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K123947 for ARCHITECT IVANCOMYCIN, Substantially Equivalent on 2013-08-29. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code LEH
Advisory panel: Clinical Toxicology
Date received: 2012-12-21
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llissa D'Amunt, Barcelona, ES

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.