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510(k) K140887

COBAS CT/NG V2.0 TEST by Roche Molecular Systems, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2014
Date Received
April 7, 2014
Clearance Type
Special
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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