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510(k) K192380

ST AIA-PACK BNP by Fujirebio Diagnostics,Inc. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2020
Date Received
August 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type

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