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FDA 510(k) Application Details - K082645
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K082645
Device Name
Test,Natriuretic Peptide
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK, DE 19714-6101 US
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Contact
VICTOR M CARRIO
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
09/11/2008
Decision Date
09/22/2008
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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