Cleared Special

ALERE BINAXNOW INFLUENZA A & B CARD

K133411 · Alere Scarborough, Inc D/B/A Binax, Inc. · Microbiology

Dec 2013

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K133411 is an FDA 510(k) clearance for the ALERE BINAXNOW INFLUENZA A & B CARD, a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX), submitted by Alere Scarborough, Inc D/B/A Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on December 5, 2013, 28 days after receiving the submission on November 7, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number	K133411 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2013
Decision Date	December 05, 2013
Days to Decision	28 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF