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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 K192380
Device Name ST AIA-PACK BNP
Applicant
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern,  PA  19355
Applicant Contact Stacey Dolan
Correspondent
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern,  PA  19355
Correspondent Contact Stacey Dolan
Regulation Number862.1117
Classification Product Code
NBC  
Date Received08/30/2019
Decision Date 08/24/2020
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
Predetermined Change
Control Plan Authorized		 No
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