QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS— 510(k) K062966

Name: FDA 510(k) clearance K062966
Creator: U.S. Food and Drug Administration
Published: 2007-01-12

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K062966 for QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS, Substantially Equivalent on 2007-01-12. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code ORH
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 2006-09-29
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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