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510(k) K133140

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV by Becton, Dickinson & CO — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
October 17, 2013
Clearance Type
Special
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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