FDA 510(k), K192380, ST AIA-PACK BNP

FDA 510(k), K192380, ST AIA-PACK BNP

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510(K) Number: K192380
Device Name: ST AIA-PACK BNP
Manufacturer: Stacey Dolan
Device Classification Name: Test, Natriuretic Peptide
Regulation Number: NBC
Classification Product Code: KXA
Date Received: 08/30/2019
Decision Date: 08/24/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry

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