FDA 510(k) Application Details - K052789

Device Classification Name Test,Natriuretic Peptide

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510(K) Number K052789
Device Name Test,Natriuretic Peptide
Applicant BIOSITE INCORPORATED
9975 Summers Ridge Road
San Diego, CA 92121 US
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Contact RACHAEL S WILLIAMSON
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Regulation Number 862.1117

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Classification Product Code NBC
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Date Received 10/03/2005
Decision Date 01/23/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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