Cleared Traditional

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

K982238 · Binax, Inc. · Microbiology
Aug 1998
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K982238 is an FDA 510(k) clearance for the BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on August 21, 1998, 57 days after receiving the submission on June 25, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K982238 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1998
Decision Date August 21, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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