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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name test, natriuretic peptide
De Novo Number DEN000010
510(K) Number K003475
Device Name TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Requester
biosite incorporated
11030 roselle st.
san diego,  CA  92121
Contact jeff dahlen
Regulation Number862.1117
Classification Product Code
NBC  
Date Received11/15/2000
Decision Date 11/20/2000
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Post-NSE
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