Cleared Traditional

K021649 - BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
(FDA 510(k) Clearance)

K021649 · Binax, Inc. · Microbiology

Sep 2002

Decision

122d

Days

Class 2

Risk

K021649 is an FDA 510(k) clearance for the BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on September 19, 2002, 122 days after receiving the submission on May 20, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K021649 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2002
Decision Date	September 19, 2002
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3328
Definition	An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.