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510(k) K132251

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) by Hologic / Gen-Probe Incorporated — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
July 19, 2013
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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