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510(k) K122718

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP by Becton, Dickinson and Company — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2013
Date Received
September 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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