Cleared Traditional

ARCHITECT IVANCOMYCIN

K123947 · Biokit, S.A. · Toxicology
Aug 2013
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K123947 is an FDA 510(k) clearance for the ARCHITECT IVANCOMYCIN, 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 review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K123947 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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