Cleared Traditional

BINAX LEGIONELLA URINARY ANTIGEN EIA

K934965 · Binax, Inc. · Microbiology
Sep 1994
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K934965 is an FDA 510(k) clearance for the BINAX LEGIONELLA URINARY ANTIGEN EIA, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on September 20, 1994, 340 days after receiving the submission on October 15, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K934965 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1993
Decision Date September 20, 1994
Days to Decision 340 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MJH — Legionella, Spp., Elisa
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3300

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