510(k) Report

Devices descending from K062109

8 later devices reach Binaxnow Influenza a & B Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092349Clearview Exact II Influenza a & B TestInverness Medical, Inc.20102—
+1K092223Modification to: Binaxnow Influenza a & B TestBinax, Inc.20091—
+1K071591Ramp Influenza a/B AssayResponse Biomedical Corp.20081—
+1K071657Tru FluMeridian Bioscience, Inc.20070—
+2K133411Alere Binaxnow Influenza a & B CardAlere Scarborough, Inc D/B/A Binax, Inc.20130—
+2K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc.20111—
+2K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp.20090—
+3K133637Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc.20130—