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510(k) K132456

BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV by Becton, Dickinson and Company — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2013
Date Received
August 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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Other clearances for product code GQG

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  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
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  • K091235 — RAMP RSV ASSAY (July 24, 2009)
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