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510(k) K070172

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE by Roche Diagnostics Corporation — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2007
Date Received
January 18, 2007
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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