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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name immunoassay method, troponin subunit
510(k) Number K231974
Device Name PATHFAST®hs-cTnI-II
Applicant
PHC Corporation
1-2-3 Shibara
Tokyo,  JP 105-0023
Applicant Contact Misato Igarashi
Correspondent
Polymedco, Inc.
510 Furnace Dock Road
Cortlandt Manor,  NY  10567
Correspondent Contact Helen Landicho
Regulation Number862.1215
Classification Product Code
MMI  
Date Received07/03/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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