FDA 510(k) Application Details - DEN000010

Device Classification Name Test,Natriuretic Peptide

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510(K) Number DEN000010
Device Name Test,Natriuretic Peptide
Applicant BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
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Contact JEFF DAHLEN
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Regulation Number 862.1117

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Classification Product Code NBC
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Date Received 11/15/2000
Decision Date 11/20/2000
Decision DENG -
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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