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FDA 510(k), K053597, I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
FDA 510(k), K053597, I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
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510(K) Number: K053597
Device Name: I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
Manufacturer: I-STAT CORPORATION
Device Classification Name: Test, Natriuretic Peptide
Regulation Number: 862.1117
Classification Product Code: NBC
Date Received: 12/23/2005
Decision Date: 07/21/2006
Regulation Medical Specialty: Clinical Chemistry
Device Name: I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
Manufacturer: I-STAT CORPORATION
Device Classification Name: Test, Natriuretic Peptide
Regulation Number: 862.1117
Classification Product Code: NBC
Date Received: 12/23/2005
Decision Date: 07/21/2006
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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