Alere Binaxnow Influenza a & B Card

FDA 510(k) K133411 · Alere Scarborough, Inc D/B/A Binax, Inc.

Substantially Equivalent

510(k) numberK133411

Submission

Device name
Alere Binaxnow Influenza a & B Card
Applicant
Alere Scarborough, Inc D/B/A Binax, Inc.
Scarborough, ME, US
Received
November 7, 2013
Decision date
December 5, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GNX – Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device class
Class I (low risk)
Regulation
21 CFR 866.3330
Specialty
Microbiology

Other 510(k)s with product code GNX

510(k)DeviceApplicantDecision
K132352SAS Flualert a & B, SAS Influenza a TestGNX · Special Sa Scientific , Ltd.08/22/2013SE
K131804Remel Xpect Flu A&BGNX · Special Remel, Inc.07/12/2013SE
K131606Sofia Influenza A+B FiaGNX · Special Quidel Corp.07/05/2013SE
K131599Quick Vue InfluenzaGNX · Special Quidel Corporation07/05/2013SE
K131619Quickvue Influenza A+BGNX · Special Quidel Corp.06/28/2013SE
K123182Osom Influenza A&B Test Model 190GNX · Special SEKISUI Diagnostics, LLC11/05/2012SE
K971494Virazyme Influenza Id Test for Influenza Types a and B VirusesGNX · Traditional Zymetx, Inc.09/10/1997SE
K924006Bartel Prima System Influenza a Enzyme ImmunoassayGNX · Traditional Baxter Healthcare Corp12/29/1992SE
K901493Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional Whittaker Bioproducts, Inc.06/27/1990SE
K893579Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional Whittaker Bioproducts, Inc.01/16/1990SE

More from Whittaker Bioproducts, Inc.

510(k)DeviceDecision
K141520Alere I Influenza a & BOCC · Traditional 06/13/2014SE
K133637Alere Influenza a & B TestPSZ · Special 12/18/2013SE
K103610Clearview Exact II Influenza a & B TestPSZ · Special 01/06/2011SE

Questions and answers

When was Alere Binaxnow Influenza a & B Card cleared by the FDA?

Alere Binaxnow Influenza a & B Card (K133411) received a 510(k) decision of Substantially Equivalent on December 5, 2013, 28 days after the submission was received.

What is the product code of K133411?

The FDA product code is GNX – Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.