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FDA 510(k) Application Details - K052789
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
862.1117
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Classification Product Code
NBC
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More FDA Info for this Product Code
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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