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510(k) K163390

iC-GPC Assay TM for use on the iC-SystemTM by Icubate, Inc. — Product Code PAM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 8, 2017
Date Received: December 2, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Gram-Positive Bacteria And Their Resistance Markers
Device Class: Class II
Regulation Number: 866.3365
Review Panel: MI
Submission Type

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

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