FDA 510(k) Application Details - K051787

Device Classification Name Test,Natriuretic Peptide

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510(K) Number K051787
Device Name Test,Natriuretic Peptide
Applicant BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
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Contact JEFFREY DAHLEN
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Regulation Number 862.1117

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Classification Product Code NBC
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Date Received 07/01/2005
Decision Date 09/22/2005
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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