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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, radioallergosorbent (rast) immunological
510(k) Number K193613
Device Name Allergen-Specific IgE Assay 12 Allergen Bundle
Hitachi Chemical Diagnostics, Inc.
630 Clyde Court
Mountain View,  CA  94043
Applicant Contact Christina Kong
Minaris Medical
575 Shirlynn Court
Los Angeles,  CA  94022
Correspondent Contact Erika Ammirati
Regulation Number866.5750
Classification Product Code
Date Received12/26/2019
Decision Date 10/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No