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510(k) K092649

ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 by Roche Diagnostics Corp. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2010
Date Received
August 28, 2009
Clearance Type
Special
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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