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FDA 510(k) Application Details - K032525
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K032525
Device Name
Test,Natriuretic Peptide
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
ANDRES HOLLE
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
08/15/2003
Decision Date
09/09/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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