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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K211199
Device Name ST AIA-PACK BNP Assay
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Applicant Contact Louise Musante
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Correspondent Contact Louise Musante
Regulation Number862.1117
Classification Product Code
NBC  
Date Received04/22/2021
Decision Date 11/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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