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FDA 510(k), K192380, ST AIA-PACK BNP
FDA 510(k), K192380, ST AIA-PACK BNP
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$149.00 USD
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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: 08/30/2019
Date Received: 08/24/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: ST AIA-PACK BNP
Manufacturer: Stacey Dolan
Device Classification Name: Test, Natriuretic Peptide
Regulation Number: NBC
Classification Product Code: 08/30/2019
Date Received: 08/24/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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