Home / 510(k) Clearances / K021789

510(k) K021789

QUICKLAB RSV by Integrated Biotechnology Corp. — Product Code GQG

K021789 is an FDA 510(k) premarket notification submitted by Integrated Biotechnology Corp. for the device "QUICKLAB RSV". The FDA issued a decision of Substantially Equivalent on November 20, 2002. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2002
Date Received
May 31, 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 for product code GQG

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K162911 — Sofia RSV FIA on Sofia 2 analyzer (February 22, 2017)
  • K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (November 15, 2013)
  • K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (November 7, 2013)
  • 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)

FDA data resources