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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 K061795
Device Name DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Applicant Contact PAMELA A JUNGA
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Correspondent Contact PAMELA A JUNGA
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Code
JIT  
Date Received06/23/2006
Decision Date 09/11/2006
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
Predetermined Change
Control Plan Authorized		 No
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