ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003— 510(k) K091884

Name: FDA 510(k) clearance K091884
Creator: U.S. Food and Drug Administration
Published: 2009-12-09

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K091884 for ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003, Substantially Equivalent on 2009-12-09. 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: 2009-06-24
Decision date: 2009-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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