FDA 510(k) Applications Submitted by ALERE SCARBOROUGH, INC D/B/A BINAX, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K141520 06/09/2014 ALERE I INFLUENZA A & B ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
K133411 11/07/2013 ALERE BINAXNOW INFLUENZA A & B CARD ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
K133637 11/07/2013 ALERE INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
K103610 12/09/2010 CLEARVIEW EXACT II INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact