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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, opiates
510(k) Number K200197
Device Name ARK Fentanyl II Assay
Applicant
ARK Diagnostics, Inc.
48089 Fremont Boulevard
Fremont,  CA  94538
Applicant Contact Thomas Houts
Correspondent
ARK Diagnostics, Inc.
48089 Fremont Boulevard
Fremont,  CA  94538
Correspondent Contact Thomas Houts
Regulation Number862.3650
Classification Product Code
DJG  
Date Received01/27/2020
Decision Date 02/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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