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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tyrosine Phosphatase (Ia-2) Autoantibody Assay
510(k) Number K220085
Device Name KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Applicant
Kronus, Inc.
170 S. Seneca Springs Way
Suite 105
Star,  ID  83669
Applicant Contact Delaney Sauer
Correspondent
Kronus, Inc.
170 S. Seneca Springs Way
Suite 105
Star,  ID  83669
Correspondent Contact Delaney Sauer
Regulation Number866.5660
Classification Product Code
OIF  
Date Received01/11/2022
Decision Date 08/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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