TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00— 510(k) K083799

Name: FDA 510(k) clearance K083799
Creator: U.S. Food and Drug Administration
Published: 2009-04-16

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K083799 for TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00, Substantially Equivalent on 2009-04-16. Applicant: Ark Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code NWM
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 2008-12-22
Decision date: 2009-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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