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510(k) K033383

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 by Biosite Incorporated — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
October 23, 2003
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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