ABBOTT CARBAMAZEPINE ASSAY— 510(k) K123518

Name: FDA 510(k) clearance K123518
Creator: U.S. Food and Drug Administration
Published: 2013-06-05

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K123518 for ABBOTT CARBAMAZEPINE ASSAY, Substantially Equivalent on 2013-06-05. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant: Microgenics Corporation
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 2012-11-14
Decision date: 2013-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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