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510(k) K113190

TRU LEGIONELLA by Meridian Bioscience, Inc. — Product Code MJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2012
Date Received
October 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legionella, Spp., Elisa
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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