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510(k) K121710

XPERT CT/NG by Cepheid — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2012
Date Received
June 11, 2012
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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