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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, Methotrexate
510(k) Number K232017
Device Name ARK Methotrexate II Assay
Applicant
Ark Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Thomas Houts
Correspondent
Ark Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Thomas Houts
Classification Product Code
LAO  
Date Received07/07/2023
Decision Date 12/20/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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