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510(k) K023779

RSV OIA by Thermo Biostar, Inc. — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2003
Date Received
November 12, 2002
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

Other clearances by Thermo Biostar, Inc.

  • K032330 — CT OIA (March 2, 2004)
  • K023947 — GC OIA (April 17, 2003)
  • K023556 — FLU OIA A/B TEST KIT (March 27, 2003)
  • K021172 — RSV OIA (September 13, 2002)

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  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
  • K101918 — QUICKVUE RSV 10 (September 24, 2010)
  • K101514 — BD DIRECTIGEN EZ RSV (July 9, 2010)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)