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510(k) K201312

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack by Ortho Clinical Diagnostics — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2021
Date Received
May 18, 2020
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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