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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 K071767
Device Name DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1117
Classification Product Code
NBC  
Date Received06/29/2007
Decision Date 08/04/2007
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
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