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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 K043476
Device Name STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG 500, MS 514 P.O.BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact GEORGE M PLUMMER
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG 500, MS 514 P.O.BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Code
JIT  
Date Received12/16/2004
Decision Date 02/15/2005
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
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