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FDA 510(k) Application Details - K032646
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K032646
Device Name
Test,Natriuretic Peptide
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46256 US
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Contact
KAY A TAYLOR
Other 510(k) Applications for this Contact
Regulation Number
862.1117
More FDA Info for this Regulation Number
Classification Product Code
NBC
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More FDA Info for this Product Code
Date Received
08/27/2003
Decision Date
11/12/2003
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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