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FDA 510(k) Application Details - K060964
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K060964
Device Name
Test,Natriuretic Peptide
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
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Contact
DIANA L WOLANIUK
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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
04/07/2006
Decision Date
05/25/2006
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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