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510(k) K032235

MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST by Biosite Incorporated — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2004
Date Received
July 21, 2003
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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