Home / 510(k) Clearances / K032166

510(k) K032166

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 by Binax, Inc. — Product Code GQG

K032166 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065". The FDA issued a decision of Substantially Equivalent on October 21, 2003. 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. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2003
Date Received
July 16, 2003
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 Binax, Inc.

  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
  • K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (August 12, 2009)
  • K080003 — BINAXNOW G6PD TEST (October 23, 2008)
  • K062109 — BINAXNOW INFLUENZA A & B TEST (November 9, 2006)
  • K053126 — BINAXNOW INFLUENZA A & B TEST (November 30, 2005)
  • K041049 — BINAXNOW INFLUENZA A & B TEST (August 10, 2004)

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