Cleared Traditional

K021687 - BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
(FDA 510(k) Clearance)

K021687 · Binax, Inc. · Microbiology
Sep 2002
Decision
114d
Days
Class 1
Risk

K021687 is an FDA 510(k) clearance for the BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on September 13, 2002, 114 days after receiving the submission on May 22, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K021687 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2002
Decision Date September 13, 2002
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3480

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