Cleared Traditional

BINAXNOX STAPHYLOCOCCUS AUREUS TEST

K090964 · Binax, Inc. · Microbiology
Dec 2009
Decision
254d
Days
Class 1
Risk

About This 510(k) Submission

K090964 is an FDA 510(k) clearance for the BINAXNOX STAPHYLOCOCCUS AUREUS TEST, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on December 16, 2009, 254 days after receiving the submission on April 6, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K090964 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2009
Decision Date December 16, 2009
Days to Decision 254 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660