Cleared Traditional

ABBOTT CARBAMAZEPINE ASSAY

K123518 · Microgenics Corporation · Toxicology
Jun 2013
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K123518 is an FDA 510(k) clearance for the ABBOTT CARBAMAZEPINE ASSAY, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on June 5, 2013, 203 days after receiving the submission on November 14, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K123518 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2012
Decision Date June 05, 2013
Days to Decision 203 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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