FDA 510(k) Application Details - K071834

Device Classification Name Test,Natriuretic Peptide

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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
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Contact GEORGE M PLUMMER
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Regulation Number 862.1117

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Classification Product Code NBC
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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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