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510(k) K090971

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY by Becton, Dickinson & CO — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
April 6, 2009
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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