ARK EDDP Assay— 510(k) K182779

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K182779 for ARK EDDP Assay, Substantially Equivalent on 2018-11-21. Applicant: Ark Diagnostics, Inc..

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code DJR
Advisory panel: Clinical Toxicology
Date received: 2018-10-01
Decision date: 2018-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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