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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, natriuretic peptide
510(k) Number K071834
Device Name STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact GEORGE M PLUMMER
Correspondent
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1117
Classification Product Code
NBC  
Date Received07/03/2007
Decision Date 08/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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