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510(k) K133411

ALERE BINAXNOW INFLUENZA A & B CARD by Alere Scarborough, Inc D/B/A Binax, Inc. — Product Code GNX

K133411 is an FDA 510(k) premarket notification submitted by Alere Scarborough, Inc D/B/A Binax, Inc. for the device "ALERE BINAXNOW INFLUENZA A & B CARD". The FDA issued a decision of Substantially Equivalent on December 5, 2013. The device falls under product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Alere Scarborough, Inc D/B/A Binax, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2013
Date Received
November 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Alere Scarborough, Inc D/B/A Binax, Inc.

  • K141520 — ALERE I INFLUENZA A & B (June 13, 2014)
  • K133637 — ALERE INFLUENZA A & B TEST (December 18, 2013)
  • K103610 — CLEARVIEW EXACT II INFLUENZA A & B TEST (January 6, 2011)

Other clearances for product code GNX

  • K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131599 — QUICK VUE INFLUENZA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)

FDA data resources