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510(k) K101514

BD DIRECTIGEN EZ RSV by Becton, Dickinson & CO — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
June 2, 2010
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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