ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL— 510(k) K101305

Name: FDA 510(k) clearance K101305
Creator: U.S. Food and Drug Administration
Published: 2010-10-29

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K101305 for ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL, Substantially Equivalent on 2010-10-29. Applicant: Ark Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code ORH
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 2010-05-10
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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