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FDA 510(k) Application Details - K071834
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K071834
Device Name
Test,Natriuretic Peptide
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
GEORGE M PLUMMER
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
07/03/2007
Decision Date
08/17/2007
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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