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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 K052789
Device Name TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
Applicant
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Applicant Contact RACHAEL S WILLIAMSON
Correspondent
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Correspondent Contact RACHAEL S WILLIAMSON
Regulation Number862.1117
Classification Product Code
NBC  
Date Received10/03/2005
Decision Date 01/23/2006
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
Recalls CDRH Recalls
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