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510(k) K080269

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS by Biosite Incorporated — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
February 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type

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