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510(k) K173887

cobas CT/NG for use on cobas 6800/8800 systems by Roche Molecular Systems, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2018
Date Received
December 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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